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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 / December 2025 / K251657

510(k) cleared

Personalized Therapy Comfort Settings (PTCS)

Resmed Corp · Dec 5, 2025 · K251657

FDA cleared the Personalized Therapy Comfort Settings (PTCS) from Resmed Corp on Dec 5, 2025 under K251657, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 30, 2025. The decision came 189 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Resmed Corp has 5 other decisions in the tracker over the last 12 months: K261360 (EasyCare Tx 2), K253553 (Orion), K254104 (ResScan Essentials), K251889 (myAir).

Questions & Answers

What did FDA clear under K251657?

K251657 is the FDA 510(k) for Personalized Therapy Comfort Settings (PTCS), submitted by Resmed Corp. FDA's decision date was Dec 5, 2025, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the Personalized Therapy Comfort Settings (PTCS)?

Resmed Corp, based in San Diego, CA, is the applicant of record for K251657.

How long did the K251657 review take?

FDA received the submission on May 30, 2025 and issued its decision on Dec 5, 2025, 189 days later.

← All decisions in December 2025

Sources