WHERE ARE YOU?

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

THE TAPE

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 / K252934

510(k) cleared

Diagnocat

DGNCT, LLC · Jan 15, 2026 · K252934

FDA cleared the Diagnocat from DGNCT, LLC on Jan 15, 2026 under K252934, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 15, 2025. The decision came 122 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 DGNCT, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252934?

K252934 is the FDA 510(k) for Diagnocat, submitted by DGNCT, LLC. FDA's decision date was Jan 15, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the Diagnocat?

DGNCT, LLC, based in Miami, FL, is the applicant of record for K252934.

How long did the K252934 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Jan 15, 2026, 122 days later.

← All decisions in January 2026