Respiration Rate algorithm— 510(k) K251326
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K251326 for Respiration Rate algorithm, Substantially Equivalent on 2026-06-11. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Summary
Edwards Lifesciences' Respiration Rate algorithm is filed under BZQ, breathing frequency monitors. The record doesn't describe the algorithm beyond its name and the code name.
Class II, 21 CFR 868.2375. Anesthesiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Edwards filed from Irvine, California. The decision came 408 calendar days after receipt (April 29, 2025 to June 11, 2026).
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Product code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code BZQ
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