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Masimo sues US Customs over Apple Watch blood oxygen return

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Masimo has sued US Customs and Border Protection (CBP) in connection with the return of blood oxygen functionality on Apple Watch. The fight isn’t just about a feature—it’s about how patent enforcement at the border is applied after Apple reworked how the sensor/feature behaves.

If you own an Apple Watch (or you’re shopping for one), this matters because CBP-related restrictions can change what’s available by model, region, and software. Below is a clear, practical guide to what’s happening, how the legal mechanism works, and how you can tell what you’ll get.

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Who’s involved: Masimo, Apple, and US Customs (CBP)

Masimo is a medical technology company known for pulse oximetry—devices and methods that measure oxygen saturation (SpO2) using light-based sensors. Apple sells Apple Watch and offers blood oxygen measurements in the Health ecosystem.

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CBP (U.S. Customs and Border Protection) is the agency that enforces certain import restrictions tied to U.S. patent litigation outcomes. In disputes like this, the “border” component turns a patent decision into practical availability limits for products entering the U.S.

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What the blood oxygen dispute is really about (SpO2 and pulse oximetry patents)

Apple Watch blood oxygen uses red and infrared light to estimate blood oxygen saturation (SpO2). The underlying technology relies on interpreting how light is absorbed and reflected through tissues over time.

Masimo’s core claim is that certain measurement approaches—how signals are captured and processed, and/or specific methods used in pulse oximetry—overlap with Masimo-held patents. Even when a product works from a consumer perspective, patent claims can still be triggered if the design and method fall within the scope of those patents.

How US Customs enforcement works in patent cases

Patent enforcement at the border in the U.S. typically flows through the U.S. International Trade Commission (USITC), not a standard courtroom trial between the parties. If the USITC issues an exclusion order, CBP uses that order to block non-compliant imports.

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That’s why CBP becomes a target in some lawsuits: if one side believes CBP is enforcing the exclusion order too narrowly (or too broadly), they may sue to force a change in how the order is applied.

Why Masimo is suing over Apple Watch blood oxygen return

When a product feature is affected by an ITC/CBP enforcement action, manufacturers sometimes respond with changes that aim to avoid the specific claims at issue. Apple has previously taken steps that affected how blood oxygen functionality was offered in the U.S., and later reintroduced availability after changes.

Masimo’s argument, in plain terms, is that CBP should treat the reintroduced blood oxygen capability as still falling within the excluded territory—or that CBP’s enforcement should be tightened when the feature returns. In disputes like this, the fight often centers on whether the modified product is truly outside the patent claims or whether the changes are insufficient.

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  • KNOW YOUR SLEEP SCORE—With advanced sleep tracking, Series 11 gives you a daily sleep score. It’s an easy way to help measure and understand the quality of your sleep, so you can make it more restorative.
  • GET HYPERTENSION NOTIFICATIONS—Did you know that Series 11 can spot signs of chronic high blood pressure? By analyzing how your blood vessels respond to beats of the heart, it can notify you of possible hypertension.*
  • SAFETY FEATURES—A smartwatch that puts your safety first. Series 11 can detect a hard fall or severe car crash, automatically help connect you with emergency services, and notify your emergency contacts.* Check In can automatically notify a loved one when you’ve arrived at your destination.
  • A POWERFUL FITNESS TRACKER—With advanced metrics and motivating features like Pacer, Heart Rate Zones, training load, and Workout Buddy powered by Apple Intelligence from your nearby iPhone*—Series 11 is made to help everyone stay active, from runners and hikers to strength-training enthusiasts.

Timeline and key milestones (high level)

Because exact dates can vary by filing and ruling, it helps to think in milestones:

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  • Masimo files patent claims at the USITC alleging infringement tied to pulse oximetry.
  • USITC issues exclusion-related relief, which CBP then implements for import enforcement.
  • Apple adjusts availability of the blood oxygen feature in the U.S., using hardware/software changes to address the enforcement concerns.
  • Blood oxygen returns for certain Apple Watch models/conditions.
  • Masimo challenges CBP enforcement (the current lawsuit) to prevent or alter that return.

If you want a bookmark-worthy reference timeline, focus on three recurring artifacts: the USITC decision(s), CBP enforcement actions/updates, and subsequent court filings challenging how CBP applied the order.

What this could change for Apple Watch customers

Depending on the outcome, the practical impact usually lands in one of three places: (1) availability of the blood oxygen feature, (2) which models are allowed into the U.S. with the feature enabled, and (3) how software updates interact with compliance.

Even if the hardware is the same, a feature can be disabled or restricted by software behavior to stay within the boundaries set by enforcement decisions. Courts and regulators may look closely at the “as imported” product configuration.

How to check whether blood oxygen is available on your Apple Watch

For most owners, verification is easiest inside Apple’s apps and settings—then supported by model identification.

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Verify in the Health app

Open the Health app on your iPhone, then look for the blood oxygen option (SpO2). If blood oxygen data collection is enabled for your watch, you should see it in the relevant health categories and be able to start a measurement flow.

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If the feature is restricted, Apple typically reflects that through missing toggles or unavailable measurement workflows.

Confirm model and software behavior

Check your watch model (Settings > General > About on watchOS). Then compare what you see against what Apple’s feature availability indicates for your specific device class.

This matters because enforcement actions can apply differently across model generations and configurations.

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Know the limits: region and watchOS version matter

Even if you bought the same watch model, your location, the iPhone region settings, and the watchOS/software version can affect whether the blood oxygen feature is visible and functional.

So a “yes” on one user’s watch doesn’t automatically mean “yes” on yours.

Potential outcomes and what each likely means

Courts can resolve these cases in multiple ways. Here are the most common patterns that affect real-world availability.

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  • GET SMARTER HEALTH INSIGHTS—Apple Watch SE 3 is an advanced health tracker that helps you better understand your body. The smartwatch sends alerts for an irregular heart rhythm, or an unusually high or low heart rate.* You can view your overnight health tracking metrics with the Vitals app,* track your sleep score, and get sleep apnea notifications.*
  • A GREAT FITNESS TRACKER—SE 3 can track your workouts in a healthy number of ways—from running and strength training to simply achieving your 10K steps a day. With real-time metrics and Workout Buddy powered by Apple Intelligence from your nearby iPhone,* you’ll hit your goals like never before.
  • KEEP HELP CLOSE AT HAND—SE 3 is a smartwatch that can detect a hard fall or severe car crash and automatically help connect you to emergency services and notify your emergency contacts.* Check In can automatically notify a loved one when you’ve arrived at your destination.
  • WOMEN’S HEALTH INSIGHTS—SE 3 has advanced sensors that track your wrist temperature while you sleep. With this smartwatch, you can log your periods and symptoms, get period predictions, and get notified of cycle deviations.*
  • GREAT BATTERY LIFE AND FASTER CHARGING—Enjoy a smartwatch with all-day, 18-hour battery life* from sunup to sundown. Then charge up to twice as fast as SE 2* and get up to 8 hours of battery in just 15 minutes.*

If the court blocks the return

CBP enforcement could shift so that imports of affected Apple Watches are restricted again, or that the feature must remain disabled for U.S.-bound configurations. You might see availability change after software updates, or simply after new shipments.

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If the court allows continued availability

Masimo could be denied the relief it seeks, meaning Apple’s current configuration remains acceptable under the enforced boundaries. In that scenario, blood oxygen should continue functioning for the same set of devices and conditions as currently offered.

If terms are narrowed to specific models/versions

A frequent outcome in hardware patent fights is narrower scope: only certain models or only certain software behaviors are deemed compliant/non-compliant. Practically, that leads to “it works on my watch but not yours.”

Common misunderstandings (and the real constraints)

  • “If it works once, it’s always legal.” Availability can change with enforcement interpretations and updated configurations shipped later.
  • “Hardware decides everything.” Software and how the feature is enabled/processed can matter for compliance.
  • “This is just a consumer dispute.” It’s a patent enforcement dispute with regulatory and import enforcement consequences.

For buyers, the most reliable approach is to check current feature behavior on the specific model you’re considering and keep an eye on software updates.

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What to watch next: enforcement signals and filings

In cases like this, the “signals” aren’t just the headline lawsuit. They tend to show up as: (1) court orders affecting enforcement timing, (2) CBP guidance or enforcement updates, and (3) Apple software changes that specifically relate to the contested measurement behavior.

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If you care about the practical outcome, track whether Apple continues to advertise the blood oxygen feature for the U.S. market on the relevant models and whether new watchOS versions keep the feature functioning.

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  • A FULL-FEATURED HEALTH TRACKER—Apple Watch Series 11 gives you invaluable insights about your body, right from your wrist. Take an ECG anytime* and get alerts for a high and low heart rate or an irregular rhythm*—so you can stay closer to your heart. You can also view your overnight health tracking metrics with the Vitals app* and be notified of possible sleep apnea.*
  • KNOW YOUR SLEEP SCORE—With advanced sleep tracking, Series 11 gives you a daily sleep score. It’s an easy way to help measure and understand the quality of your sleep, so you can make it more restorative.
  • GET HYPERTENSION NOTIFICATIONS—Did you know that Series 11 can spot signs of chronic high blood pressure? By analyzing how your blood vessels respond to beats of the heart, it can notify you of possible hypertension.*
  • SAFETY FEATURES—A smartwatch that puts your safety first. Series 11 can detect a hard fall or severe car crash, automatically help connect you with emergency services, and notify your emergency contacts.* Check In can automatically notify a loved one when you’ve arrived at your destination.
  • A POWERFUL FITNESS TRACKER—With advanced metrics and motivating features like Pacer, Heart Rate Zones, training load, and Workout Buddy powered by Apple Intelligence from your nearby iPhone*—Series 11 is made to help everyone stay active, from runners and hikers to strength-training enthusiasts.

Bottom Line

Masimo’s lawsuit over CBP enforcement is aimed at controlling whether Apple Watch’s blood oxygen capability remains available in the U.S. after Apple’s earlier adjustments. These disputes can directly change what features are enabled for importable configurations, not just what’s theoretically possible on hardware.

If blood oxygen is a must-have for you, verify availability in the Health app on the specific watch model you’re buying, and treat future software updates as a variable—not a footnote.

FAQs

Will this affect Apple Watch already purchased?

It can. If restrictions are tied to software behavior or future shipments, the effect may show up after updates or by changing what new units support. Many owners see differences only when functionality is altered via software.

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How can I confirm right now if blood oxygen works on my watch?

Check the Health app for blood oxygen/SPo2 availability and start a measurement. If the option is missing or blocked, your configuration likely doesn’t include the feature as currently enabled.

Does a lawsuit mean the feature is automatically turned off?

No. A lawsuit is a request for relief. The feature typically changes only if a court order, enforcement action, or software update requires it.

What models are typically involved in these disputes?

In this controversy, the dispute has focused on recent Apple Watch generations that included blood oxygen functionality. The exact coverage depends on what the enforcement orders apply to and what Apple changed to respond.

Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.

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