WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K254185

510(k) cleared

Potenza Prime

Jeisys Medical Incorporated · Sep 11, 2026 · K254185

FDA cleared the Potenza Prime from Jeisys Medical Incorporated on Sep 11, 2026 under K254185, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 23, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jeisys Medical Incorporated has one other decision in the tracker over the last 12 months: K251464 (TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)).

Questions & Answers

What did FDA clear under K254185?

K254185 is the FDA 510(k) for Potenza Prime, submitted by Jeisys Medical Incorporated. FDA's decision date was Sep 11, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Potenza Prime?

Jeisys Medical Incorporated, based in Seoul, is the applicant of record for K254185.

How long did the K254185 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 11, 2026, 262 days later.

← All decisions in September 2026

Sources