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FDA 510(k)

BreatheBand® (Model 1000)

K-Number: K250860 · 2025-10-02

ApplicantExemplar Medical, LLC
Decision Date2025-10-02
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BreatheBand® (Model 1000) is the device name listed in this FDA 510(k) record. The listed applicant is Exemplar Medical, LLC. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K250860. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BreatheBand® (Model 1000)?

BreatheBand® (Model 1000) is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Exemplar Medical, LLC. The 510(k) number is K250860.

When did BreatheBand® (Model 1000) receive FDA 510(k) clearance?

BreatheBand® (Model 1000) received FDA 510(k) clearance on 2025-10-02, under 510(k) number K250860.

Who is the listed applicant for BreatheBand® (Model 1000)?

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

What is the FDA product code for BreatheBand® (Model 1000)?

The FDA product code for BreatheBand® (Model 1000) is BYI.

Related Devices (Code: BYI)

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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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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