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FDA 510(k)

NightGuard Aire Max

K-Number: K252698 · 2025-11-03

ApplicantNightguard Express, LLC
Decision Date2025-11-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NightGuard Aire Max is the device name listed in this FDA 510(k) record. The listed applicant is Nightguard Express, LLC. It received FDA 510(k) clearance on 2025-11-03 under 510(k) number K252698. 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 NightGuard Aire Max?

NightGuard Aire Max is a medical device that received FDA 510(k) clearance on 2025-11-03. The listed applicant is Nightguard Express, LLC. The 510(k) number is K252698.

When did NightGuard Aire Max receive FDA 510(k) clearance?

NightGuard Aire Max received FDA 510(k) clearance on 2025-11-03, under 510(k) number K252698.

Who is the listed applicant for NightGuard Aire Max?

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

What is the FDA product code for NightGuard Aire Max?

The FDA product code for NightGuard Aire Max is LRK.

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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