Respiration Rate algorithm
FDA 510(k) K251326 · Edwards Lifesciences, LLC
510(k) numberK251326
Submission
- Device name
- Respiration Rate algorithm
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- April 29, 2025
- Decision date
- June 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Respiration Rate algorithm cleared by the FDA?
Respiration Rate algorithm (K251326) received a 510(k) decision of Substantially Equivalent on June 11, 2026, 408 days after the submission was received.
What is the product code of K251326?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.