Clearance Summary
Respiration Rate algorithm received FDA 510(k) clearance under submission number K251326, sponsored by Edwards Lifesciences, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-06-11.
- Submission: K251326
- Applicant / Sponsor: Edwards Lifesciences, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2026-06-11
Classification & Regulation
This clearance is catalogued under FDA product code BZQ and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.