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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 / May 2026 / K252772

510(k) cleared

Arc Adjustable Radial Cuff Compression Device

Tz Medical, Inc. · May 22, 2026 · K252772

FDA cleared the Arc Adjustable Radial Cuff Compression Device from Tz Medical, Inc. on May 22, 2026 under K252772, a traditional 510(k). The device falls under product code DXC, Clamp, Vascular, regulated at 21 CFR 870.4450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 2, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tz Medical, Inc. has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K252772?

K252772 is the FDA 510(k) for Arc Adjustable Radial Cuff Compression Device, submitted by Tz Medical, Inc.. FDA's decision date was May 22, 2026, under product code DXC (Clamp, Vascular).

Who makes the Arc Adjustable Radial Cuff Compression Device?

Tz Medical, Inc., based in Tualatin, OR, is the applicant of record for K252772.

How long did the K252772 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on May 22, 2026, 262 days later.

← All decisions in May 2026