510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091470Substantially Equivalent

Ranasys Ez Negative Pressure Wound Therapy System, Model 66800059

Smith & Nephew, Inc., St Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091470 is the FDA 510(k) clearance record for RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP reads: "For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of...". FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show one recall naming K091470.

Clearance record

Decision date
Received
(52 days to decision)
Product code
OMP Negative Pressure Wound Therapy Powered Suction Pump
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Smith & Nephew, Inc. 970 Lake Carillon Dr., St Petersburg FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMP

Trailing 12 months
8 clearances under product code OMP in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OMP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20263
June 20262
July 20260
August 20260
September 20261
October 20260