WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K251646

510(k) cleared

extriCARE® 1000 Negative Pressure Wound Therapy System

Alleva Medical Devices · Oct 3, 2025 · K251646

FDA cleared the extriCARE® 1000 Negative Pressure Wound Therapy System from Alleva Medical Devices on Oct 3, 2025 under K251646, a traditional 510(k). The device falls under product code OMP, Negative Pressure Wound Therapy Powered Suction Pump, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 29, 2025. The decision came 127 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 Alleva Medical Devices in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251646?

K251646 is the FDA 510(k) for extriCARE® 1000 Negative Pressure Wound Therapy System, submitted by Alleva Medical Devices. FDA's decision date was Oct 3, 2025, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the extriCARE® 1000 Negative Pressure Wound Therapy System?

Alleva Medical Devices, based in Brea, CA, is the applicant of record for K251646.

How long did the K251646 review take?

FDA received the submission on May 29, 2025 and issued its decision on Oct 3, 2025, 127 days later.

← All decisions in October 2025