Cleared Traditional

Respiration Rate algorithm (K251326) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251326 · Edwards Lifesciences, LLC · Anesthesiology device
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Jun 2026
Decision
408d
Days
Class 2
Risk

K251326 is an FDA 510(k) clearance for the Respiration Rate algorithm. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 11, 2026 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K251326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2025
Decision Date June 11, 2026
Days to Decision 408 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 140d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 33
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K251326.
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · Linshom Medical, Inc. · Sep 2025
Respiree Cardio- Respiratory Monitor System
K250934 · Respiree Pte, Ltd. · Aug 2025
RTMsense Respiratory Monitoring System
K243183 · Rtm Vital Signs, LLC · Jun 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966 · Faceheart Corp. · Apr 2025
Philips VSC-MEDlib
K242001 · Philips Medical Systems Nederland B.V. · Apr 2025
Makani Science™ Respiration Monitoring System
K233953 · Makani Science, Inc. · Mar 2025