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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 / K251826

510(k) cleared

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

Smith & Nephew Medical, Ltd. · Sep 11, 2025 · K251826

FDA cleared the RENASYS WOUND+ Dressing Kit with AIRLOCK Technology from Smith & Nephew Medical, Ltd. on Sep 11, 2025 under K251826, 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 Jun 13, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Smith & Nephew Medical, Ltd. has 6 other decisions in the tracker over the last 12 months: K261968 (Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)), DEN250037 (TESSA Spatial Surgery System; INTELLIO Tablet (72205455)), K260646 (RENASYS EDGE (66803126)), K254084 (AETOS Shoulder System - CONCELOC Glenoids).

Questions & Answers

What did FDA clear under K251826?

K251826 is the FDA 510(k) for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology, submitted by Smith & Nephew Medical, Ltd.. FDA's decision date was Sep 11, 2025, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the RENASYS WOUND+ Dressing Kit with AIRLOCK Technology?

Smith & Nephew Medical, Ltd., based in Hull, is the applicant of record for K251826.

How long did the K251826 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Sep 11, 2025, 90 days later.

← All decisions in September 2025