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Masimo’s lawsuit challenging U.S. Customs and Border Protection’s approval of a redesigned Apple Watch is over: the U.S. International Trade Commission (ITC) found the redesigned watch’s importation did not violate its existing exclusion order, and Masimo and Customs dismissed their separate court case. That does not erase the original infringement ruling or end the broader Masimo–Apple disputes.
Why did Masimo sue US Customs over Apple Watch blood oxygen?
Masimo challenged Customs’ August 1, 2025 ruling that allowed importation of a redesigned Apple Watch. In a company filing, Masimo said its August 20 lawsuit in the U.S. District Court for the District of Columbia alleged a violation of the Administrative Procedure Act tied to Apple’s ex parte proceeding before Customs. Masimo also sought temporary and preliminary injunctive relief.
The challenge was about how Customs reached its import decision and whether that decision was lawful. It was separate from Masimo’s original complaint to the ITC, which alleged that Apple imported and sold watches using light-based pulse oximetry that infringed Masimo patents.
What happened to the Customs lawsuit?
- August 1, 2025: Customs’ Exclusion Order Enforcement Branch issued its ruling allowing importation of the redesigned watch.
- August 20, 2025: Masimo filed its challenge in the District of Columbia and sought emergency 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 a final determination that importing the redesigned watch did not violate the existing limited exclusion order.
- April 28, 2026: Masimo and Customs agreed to dismiss the court case. Bloomberg Law reported that Judge Ana C. Reyes 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 US?
The ITC’s April 17 determination was favorable to importation of the redesigned watch considered in that enforcement proceeding: the Commission found that its importation did not violate the existing limited exclusion order. That is the specific conclusion established by the ruling; it should not be read as a blanket ruling that every Apple Watch model or configuration with blood-oxygen functionality is free of restrictions.
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The original limited exclusion order concerned watches the ITC found infringing. On March 19, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed that original ITC determination. The court wrote: “Finding no error in the Commission’s domestic industry determination, its validity rulings, or its infringement findings, we affirm.” That appeal addressed the original determination, not whether the later redesign violated the order.
How do the original ruling and the redesign ruling differ?
| Issue | Original ITC case | Redesign enforcement proceeding |
|---|---|---|
| Product question | Whether Apple Watch models with light-based pulse oximetry infringed Masimo patents. | Whether importing the redesigned watch covered by Customs’ August 2025 ruling violated the existing exclusion order. |
| Decision-maker and result | The ITC found infringement and issued a limited exclusion order; the Federal Circuit affirmed that determination on March 19, 2026. | The ITC found on April 17, 2026 that importing the redesign did not violate the order. |
| What followed | The original exclusion order remained in place after the Federal Circuit appeal. | The separate Customs lawsuit was dismissed on April 28, 2026. |
These outcomes are not contradictory: they concern different product versions and different questions. The redesign determination did not reverse the original infringement findings, while the Federal Circuit’s affirmance did not decide whether the redesign violated the order.
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Is the $634 million award part of the Customs case?
No. The award came from separate patent litigation between Masimo and Apple in California, not from Masimo’s challenge to Customs. A jury returned a $634 million verdict in November 2025; the U.S. District Court for the Central District of California entered final judgment on July 20, 2026, awarding $634,313,913 on the patent claims. It is not damages awarded in the Customs lawsuit.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What is—and is not—over?
The lawsuit over Customs’ approval has been dismissed, following the ITC’s finding that importation of the specific redesign did not violate the existing order. The original ITC infringement determination was affirmed, and the separate California patent case produced its own judgment. Those proceedings have distinct records and outcomes; the Customs dismissal alone does not establish that every dispute between Masimo and Apple has ended.
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