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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 / K262664

510(k) cleared

Rongjian Self-adhesive Electrode

Bozhou Rongjian Medical Appliance Co., Ltd. · Oct 20, 2026 · K262664

FDA cleared the Rongjian Self-adhesive Electrode from Bozhou Rongjian Medical Appliance Co., Ltd. on Oct 20, 2026 under K262664, a traditional 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 30, 2026. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

Bozhou Rongjian Medical Appliance Co., Ltd. has one other decision in the tracker over the last 12 months: K252688 (Transcutaneous Electrical Nerve Stimulator (RJTENS-2)).

Questions & Answers

What did FDA clear under K262664?

K262664 is the FDA 510(k) for Rongjian Self-adhesive Electrode, submitted by Bozhou Rongjian Medical Appliance Co., Ltd.. FDA's decision date was Oct 20, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Rongjian Self-adhesive Electrode?

Bozhou Rongjian Medical Appliance Co., Ltd., based in Bozhou, is the applicant of record for K262664.

How long did the K262664 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Oct 20, 2026, 82 days later.

← All decisions in October 2026

Sources