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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

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