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FDA 510(k)

SleepRes PAP System

K-Number: K251770 · 2025-12-15

ApplicantSleepres, Inc.
Decision Date2025-12-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SleepRes PAP System is the device name listed in this FDA 510(k) record. The listed applicant is Sleepres, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K251770. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SleepRes PAP System?

SleepRes PAP System is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Sleepres, Inc.. The 510(k) number is K251770.

When did SleepRes PAP System receive FDA 510(k) clearance?

SleepRes PAP System received FDA 510(k) clearance on 2025-12-15, under 510(k) number K251770.

Who is the listed applicant for SleepRes PAP System?

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

What is the FDA product code for SleepRes PAP System?

The FDA product code for SleepRes PAP System is BZD.

Related Clinical Trials

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.

NCT07530523KPAP vs EPR for EfficacyNOT_YET_RECRUITINGNCT07751562KPAP vs AirSense 11 With EPRNOT_YET_RECRUITINGNCT06413134KPAP Adherence Crossover StudyNOT_YET_RECRUITINGNCT07530510KPAP vs EPR for ComfortNOT_YET_RECRUITING

Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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