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The Tracker / September 2026 / K261338

510(k) cleared

RENASYS DYNAFLOW Kit (66807741)

Smith & Nephew Medical, Ltd. · Sep 11, 2026 · K261338

FDA cleared the RENASYS DYNAFLOW Kit (66807741) from Smith & Nephew Medical, Ltd. on Sep 11, 2026 under K261338, 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 Apr 23, 2026. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Smith & Nephew Medical, Ltd. has 7 other decisions in the tracker over the last 12 months: K261462 (LANDMARK Total Knee System), 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)).

Questions & Answers

What did FDA clear under K261338?

K261338 is the FDA 510(k) for RENASYS DYNAFLOW Kit (66807741), submitted by Smith & Nephew Medical, Ltd.. FDA's decision date was Sep 11, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the RENASYS DYNAFLOW Kit (66807741)?

Smith & Nephew Medical, Ltd., based in Hull, is the applicant of record for K261338.

How long did the K261338 review take?

FDA received the submission on Apr 23, 2026 and issued its decision on Sep 11, 2026, 141 days later.

← All decisions in September 2026