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FDA 510(k)

AIO Breathe

K-Number: K252525 · 2025-11-06

ApplicantAiomega, LLC
Decision Date2025-11-06
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIO Breathe is the device name listed in this FDA 510(k) record. The listed applicant is Aiomega, LLC. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252525. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIO Breathe?

AIO Breathe is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Aiomega, LLC. The 510(k) number is K252525.

When did AIO Breathe receive FDA 510(k) clearance?

AIO Breathe received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252525.

Who is the listed applicant for AIO Breathe?

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

What is the FDA product code for AIO Breathe?

The FDA product code for AIO Breathe is LRK.

Other records listing Aiomega, 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.

K233754AIO Breathe

Related Devices (Code: LRK)

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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