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Masimo’s lawsuit challenging U.S. Customs and Border Protection’s approval of Apple’s redesigned Apple Watch is over: the ITC found on April 17, 2026, that importing the redesign did not violate the existing exclusion order, and Masimo and Customs dismissed their separate court case on April 28. That result did not undo the original ITC infringement ruling, which the Federal Circuit affirmed in March 2026.
Why did Masimo sue U.S. Customs over Apple Watch blood oxygen?
Masimo challenged Customs’ August 1, 2025 ruling that allowed importation of a redesigned Apple Watch. In a lawsuit filed in the U.S. District Court for the District of Columbia on August 20, Masimo alleged, among other things, that the agency violated the Administrative Procedure Act in connection with Apple’s ex parte proceeding before Customs. Masimo also sought temporary and preliminary injunctive relief.
The lawsuit challenged Customs’ decision-making process and its import ruling. It was separate from the ITC proceeding that addressed whether the redesigned watch violated the existing exclusion order.
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What happened to the Customs lawsuit?
- August 1, 2025: Customs’ Exclusion Order Enforcement Branch issued its ruling allowing importation of a redesigned Apple Watch.
- August 20, 2025: Masimo filed its challenge in the District of Columbia and sought injunctive relief.
- November 14, 2025: The ITC instituted a combined enforcement and modification proceeding after Masimo asked the Commission to clarify or modify its order to cover the redesign.
- April 17, 2026: The ITC issued its final determination that importing the redesigned watch did not violate the limited exclusion order.
- April 28, 2026: Masimo and Customs agreed to dismiss their court case. Bloomberg Law reported that the court entered a minutes order that day and that the dismissal resolved all claims and counterclaims.
Can Apple still sell Apple Watches with blood oxygen in the U.S.?
The ITC’s April 17, 2026 determination was specific: it found that importing the redesigned watch at issue did not violate the existing limited exclusion order. It was not a ruling that every Apple Watch with blood-oxygen functionality, in every configuration, is free of legal restrictions. The original order remains important, and other litigation between the companies is separate.
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![Apple Watch Series 11 [GPS 42mm] Smartwatch with Rose Gold Aluminum Case with Light Blush Sport Band - S/M. Sleep Score, Fitness Tracker, Health Monitoring, Always-On Display, Water Resistant](https://m.media-amazon.com/images/I/31caPPnRysL._SL160_.jpg)
Apple Watch Series 11 [GPS 42mm] Smartwatch with Rose Gold Aluminum Case with Light Blush Sport Band - S/M. Sleep Score, Fitness Tracker, Health Monitoring, Always-On Display, Water Resistant
- 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.
The original ITC case concerned Apple Watch models with light-based pulse oximetry functionality. The Commission issued a limited exclusion order concerning infringing watches, and the Federal Circuit affirmed that original determination on March 19, 2026. The Federal Circuit’s decision did not decide whether the later redesign violated the order; the ITC addressed that enforcement question in April.
How do the original ruling and redesign decision differ?
| Issue | Original ITC case | Redesign enforcement proceeding |
|---|---|---|
| Product considered | Apple Watch models with light-based pulse oximetry functionality alleged to infringe Masimo patents | The redesigned watch covered by Customs’ August 1, 2025 import ruling |
| Decision-maker and question | The ITC decided the infringement case; the Federal Circuit reviewed that determination | The ITC considered whether importing the redesign violated the existing exclusion order |
| Outcome | The ITC issued a limited exclusion order concerning infringing watches; the Federal Circuit affirmed the original determination on March 19, 2026 | The ITC found on April 17, 2026, that importation of the redesign did not violate the order |
Does the dismissal end the Masimo–Apple dispute?
No. The April dismissal closed the lawsuit between Masimo and Customs over Customs’ approval of the redesign. It did not erase the original ITC order or resolve every dispute between Masimo and Apple. In particular, a separate patent case in California produced a different result: a jury returned a $634 million verdict in November 2025, and a July 20, 2026 final judgment awarded $634,313,913 on the patent claims. That award was not damages in the Customs lawsuit.
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Apple Watch Series 7 (GPS, 45mm) Midnight Aluminum Case with Midnight Sport Band (Renewed)
- Larger Always-On Display: Expanded Retina display with thinner borders provides more screen area for apps and notifications.
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Fitness Tracker with Heart Rate Blood Oxygen Blood Pressure Monitor Sleep Tracker Activity Trackers
- 【Superb Visual Experience & Effortless Operation】Diving into the latest 1.58'' ultra high resolution display technology, every interaction on the fitness watch is a visual delight with vibrant colors and crisp clarity. Its always on display clock makes the time conveniently visible. Experience convenience like never before with the intuitive full touch controls and the side button, switch between apps, and customize settings with seamless precision.
- 【Comprehensive 24/7 Health Monitoring】The fitness watches for women and men packs 24/7 heart rate, 24/7 blood pressure and blood oxygen monitors. You could check those real-time health metrics anytime, anywhere on your wrist and view the data record in the App. The heart rate monitor watch also tracks different sleep stages for light and deep sleep,and the time when you wake up, helps you to get a better understanding of your sleep quality.
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- 【Essential Assistant for Daily Life】The fitness watches for women and men provide you with more features including drinking water and sedentary reminder, women's menstrual period reminder, breath training, real-time weather display, remote camera shooting, music control,timer, stopwatch, finding phone, alarm clock, making it a considerate life assistant. With the GPS connectivity, you could get a map of your workout route in the app for outdoor activity by connecting to your phone GPS.
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![Apple Watch Series 9 [GPS 45mm] Midnight Aluminum Case with Midnight Sport Band M/L (Renewed)](https://m.media-amazon.com/images/I/41d-SELeXML._SL160_.jpg)
Apple Watch Series 9 [GPS 45mm] Midnight Aluminum Case with Midnight Sport Band M/L (Renewed)
- WHY APPLE WATCH SERIES 9-Your essential companion for a healthy life is now even more powerful. The S9 chip enables a superbright display and a magical new way to quickly and easily interact with your Apple Watch without touching the screen. Advanced health, safety, and activity features provide powerful insights and help when you need it. And redesigned apps in watchOS give you more information at a glance.
- CARBON NEUTRAL - An aluminum Apple Watch Series 9 paired with the latest Sport Loop is carbon neutral.
- ADVANCED HEALTH FEATURES-Keep an eye on your blood oxygen. Take an anytime. Get notifications if you have an irregular heart rhythm. See how much time you spent in REM, Core, or Deep sleep with sleep stages. Temperature sensing provides insights into overall well-being and cycle tracking. And take note of your state of mind to help build emotional awareness and resilience.
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MorePro Fitness Tracker with 24/7 Heart Rate & Blood Pressure Monitor, Blood Oxygen & Sleep Tracker, Smart Watch with Step Calorie Counter, IP68 Waterproof Activity Tracker for Women Men Android iOS
- 【Advanced Health Fitness Tracker】-This fitness tracker offers 24/7 heart rate and blood pressure monitoring to help you stay proactive about your health goals. It also supports on-demand blood oxygen checks, so you can quickly see your O₂ level whenever you need it. Detailed sleep tracking (deep sleep, light sleep and wake-ups) and all-day activity tracking give you a clearer picture of your overall health trends. (Inspire a healthy life, not for medical use
- 【All-Day Activity & Fitness Tracking】-The MorePro fitness tracker for women and men offers 120+ sport modes including running, walking and more, so you can track the workouts you actually do. With a built-in pedometer step counter, this smart watch records steps, distance, calories burned, heart rate and training time in real time, giving you clear references for exercise intensity. Whether you’re at the gym, on a run or playing ball with friends, every workout becomes safer, more efficient and easier to enjoy
- 【Women’s Health & Cycle Tracking】-Designed as a women’s health tracker, the smart watches for women offers intuitive menstrual cycle tracking right on your wrist. Use the built-in period tracker to log your menstrual period, safe days, ovulation window and ovulation day, while the app supports period mode, trying-to-conceive mode and pregnancy mode to match different life stages. Whether you’re at work, in class or relaxing at home, gentle women’s health reminders help you prepare in advance with the right clothes and pads, so every month feels more predictable and in control
- 【Everyday Smart Lifestyle Companion】-Stay connected without constantly checking your phone. This smart watch fitness tracker delivers real-time call, SMS and app message notifications on your wrist, so you can see who’s contacting you while you’re in a meeting, commuting or working out. The IP68 waterproof design easily handles sweat, rain and hand-washing. With over 200 watch faces and simple DIY custom faces using your own photos, you can quickly match your watch to business, workout or casual looks
- 【Practical Daily Smart Tools】-From sedentary reminders and drink water reminders to on-wrist weather forecasts, this smart watch helps you build healthier routines at work or while studying. Use music control and camera control while your phone stays in your bag, and rely on the stopwatch, timer, alarm clock and find my phone features to keep workouts, cooking and busy mornings on track
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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