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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / January 2026 / K251435

510(k) cleared

InbellaIgnite RF System

Inbella Medical, Inc. · Jan 27, 2026 · K251435

FDA cleared the InbellaIgnite RF System from Inbella Medical, Inc. on Jan 27, 2026 under K251435, 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 May 8, 2025. The decision came 264 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 Inbella Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251435?

K251435 is the FDA 510(k) for InbellaIgnite RF System, submitted by Inbella Medical, Inc.. FDA's decision date was Jan 27, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the InbellaIgnite RF System?

Inbella Medical, Inc., based in Richmond Hill, is the applicant of record for K251435.

How long did the K251435 review take?

FDA received the submission on May 8, 2025 and issued its decision on Jan 27, 2026, 264 days later.

← All decisions in January 2026