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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 / K260230

510(k) cleared

Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)

Suzhou Medical Appliance Factory · Oct 22, 2026 · K260230

FDA cleared the Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) from Suzhou Medical Appliance Factory on Oct 22, 2026 under K260230, a traditional 510(k). The device falls under product code BWK, Stimulator, Electro-Acupuncture as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jan 26, 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 Medical Appliance Factory in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260230?

K260230 is the FDA 510(k) for Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V), submitted by Suzhou Medical Appliance Factory. FDA's decision date was Oct 22, 2026, under product code BWK (Stimulator, Electro-Acupuncture).

Who makes the Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)?

Suzhou Medical Appliance Factory, based in Suzhou, is the applicant of record for K260230.

How long did the K260230 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Oct 22, 2026, 269 days later.

← All decisions in October 2026