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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 / February 2026 / K251852

510(k) cleared

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

VPIX Medical, Inc. · Feb 13, 2026 · K251852

FDA cleared the cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) from VPIX Medical, Inc. on Feb 13, 2026 under K251852, a traditional 510(k). The device falls under product code OWN, Confocal Optical Imaging, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 17, 2025. The decision came 241 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

VPIX Medical, Inc. has one other decision in the tracker over the last 12 months: K254030 (cCeLL405).

Questions & Answers

What did FDA clear under K251852?

K251852 is the FDA 510(k) for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200), submitted by VPIX Medical, Inc.. FDA's decision date was Feb 13, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

VPIX Medical, Inc., based in Daejeon, is the applicant of record for K251852.

How long did the K251852 review take?

FDA received the submission on Jun 17, 2025 and issued its decision on Feb 13, 2026, 241 days later.

← All decisions in February 2026

Sources