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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 / October 2026 / K260136

510(k) cleared

Forza

True Function Laboratory, Inc. · Oct 6, 2026 · K260136

FDA cleared the Forza from True Function Laboratory, Inc. on Oct 6, 2026 under K260136, a abbreviated 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 16, 2026. The decision came 263 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 True Function Laboratory, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260136?

K260136 is the FDA 510(k) for Forza, submitted by True Function Laboratory, Inc.. FDA's decision date was Oct 6, 2026, under product code LRK (Device, Anti-Snoring).

Who makes the Forza?

True Function Laboratory, Inc., based in La Mesa, CA, is the applicant of record for K260136.

How long did the K260136 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on Oct 6, 2026, 263 days later.

← All decisions in October 2026