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FDA 510(k)

BreathCare PAP III (YH-390N)

K-Number: K260251 · 2026-10-23

ApplicantSuzhou Yuyue Medical Technology Co., Ltd.
Decision Date2026-10-23
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BreathCare PAP III (YH-390N) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Yuyue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K260251. 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 BreathCare PAP III (YH-390N)?

BreathCare PAP III (YH-390N) is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Suzhou Yuyue Medical Technology Co., Ltd.. The 510(k) number is K260251.

When did BreathCare PAP III (YH-390N) receive FDA 510(k) clearance?

BreathCare PAP III (YH-390N) received FDA 510(k) clearance on 2026-10-23, under 510(k) number K260251.

Who is the listed applicant for BreathCare PAP III (YH-390N)?

The FDA 510(k) record lists Suzhou Yuyue Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BreathCare PAP III (YH-390N)?

The FDA product code for BreathCare PAP III (YH-390N) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Suzhou Yuyue Medical Technology Co., Ltd. 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.

K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask

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.

K261262Altis Full Face MaskRespironics, Inc.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.

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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