BreathCare PAP III (YH-390N)— 510(k) K260251

Name: FDA 510(k) clearance K260251
Creator: U.S. Food and Drug Administration
Published: 2026-10-23

Substantially Equivalent

Suzhou Yuyue Medical Technology Co., Ltd.

FDA 510(k) clearance K260251 for BreathCare PAP III (YH-390N), Substantially Equivalent on 2026-10-23. Applicant: Suzhou Yuyue Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Yuyue Medical Technology Co., Ltd.
Product code: Product code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2026-01-27
Decision date: 2026-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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K253044 — RXiBreeze PAP System (RXiBreeze 20C)2026-07-23
K253553 — Orion2026-06-04
K254104 — ResScan Essentials2026-05-27
K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask2026-05-21

More clearances from Suzhou Yuyue Medical Technology Co., Ltd.

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K203347 — Sleep 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 Mask2021-07-02

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.