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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 / July 2026 / K251908

510(k) cleared

Emanate Tray

Emanate Biomedical · Jul 29, 2026 · K251908 · In the directory

FDA cleared the Emanate Tray from Emanate Biomedical on Jul 29, 2026 under K251908, a traditional 510(k). The device falls under product code OLR, Oral Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 20, 2025. The decision came 404 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 Emanate Biomedical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251908?

K251908 is the FDA 510(k) for Emanate Tray, submitted by Emanate Biomedical. FDA's decision date was Jul 29, 2026, under product code OLR (Oral Wound Dressing).

Who makes the Emanate Tray?

Emanate Biomedical, based in New York, NY, is the applicant of record for K251908. The company is listed in the MedDevice Startups directory.

How long did the K251908 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Jul 29, 2026, 404 days later.

← All decisions in July 2026