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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K260251

510(k) cleared

BreathCare PAP III (YH-390N)

Suzhou Yuyue Medical Technology Co., Ltd. · Oct 23, 2026 · K260251

FDA cleared the BreathCare PAP III (YH-390N) from Suzhou Yuyue Medical Technology Co., Ltd. on Oct 23, 2026 under K260251, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 27, 2026. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Suzhou Yuyue Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260251?

K260251 is the FDA 510(k) for BreathCare PAP III (YH-390N), submitted by Suzhou Yuyue Medical Technology Co., Ltd.. FDA's decision date was Oct 23, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the BreathCare PAP III (YH-390N)?

Suzhou Yuyue Medical Technology Co., Ltd., based in Suzhou, is the applicant of record for K260251.

How long did the K260251 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Oct 23, 2026, 269 days later.

← All decisions in October 2026