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FDA 510(k)

Respiration Rate algorithm

K-Number: K251326 · 2026-06-11

ApplicantEdwards Lifesciences, LLC
Decision Date2026-06-11
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respiration Rate algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K251326. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Respiration Rate algorithm?

Respiration Rate algorithm is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251326.

When did Respiration Rate algorithm receive FDA 510(k) clearance?

Respiration Rate algorithm received FDA 510(k) clearance on 2026-06-11, under 510(k) number K251326.

Who is the listed applicant for Respiration Rate algorithm?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respiration Rate algorithm?

The FDA product code for Respiration Rate algorithm is BZQ.

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Other records listing Edwards Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253274BedDot (G1)Intelligent Dots, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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