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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 / September 2025 / K251905

510(k) cleared

Normatec Elite Hip

NormaTec Industries, LP · Sep 18, 2025 · K251905

FDA cleared the Normatec Elite Hip from NormaTec Industries, LP on Sep 18, 2025 under K251905, a traditional 510(k). The device falls under product code IRP, Massager, Powered Inflatable Tube, regulated at 21 CFR 890.5650 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jun 20, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for NormaTec Industries, LP in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251905?

K251905 is the FDA 510(k) for Normatec Elite Hip, submitted by NormaTec Industries, LP. FDA's decision date was Sep 18, 2025, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Normatec Elite Hip?

NormaTec Industries, LP, based in Watertown, MA, is the applicant of record for K251905.

How long did the K251905 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Sep 18, 2025, 90 days later.

← All decisions in September 2025