510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K132004Substantially Equivalent

Npwt Wound Dressing Kit- Medium, Npwt Wound Dressing Kit- Large

Creo Quality, LLC, Martinsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132004 is the FDA 510(k) clearance record for NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE, a class II device, cleared for Creo Quality, LLC 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 one 510(k) clearance for Creo Quality, LLC. As of , FDA records show no recalls naming K132004.

Clearance record

Decision date
Received
(305 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
Creo Quality, LLC P.O. Box 1784, Martinsville IN
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