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 / May 2026 / K260646

510(k) cleared

RENASYS EDGE (66803126)

Smith & Nephew Medical, Ltd. · May 27, 2026 · K260646

FDA cleared the RENASYS EDGE (66803126) from Smith & Nephew Medical, Ltd. on May 27, 2026 under K260646, 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 Feb 27, 2026. The decision came 89 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)), K254084 (AETOS Shoulder System - CONCELOC Glenoids), K252416 (AETOS Shoulder System Meta Humeral Prosthesis Size 0).

Questions & Answers

What did FDA clear under K260646?

K260646 is the FDA 510(k) for RENASYS EDGE (66803126), submitted by Smith & Nephew Medical, Ltd.. FDA's decision date was May 27, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the RENASYS EDGE (66803126)?

Smith & Nephew Medical, Ltd., based in Hull, is the applicant of record for K260646.

How long did the K260646 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on May 27, 2026, 89 days later.

← All decisions in May 2026