510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K212971Substantially Equivalent

NPseal

Guard Medical, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212971 is the FDA 510(k) clearance record for NPseal, a class II device, cleared for Guard Medical, Inc. on under FDA product code OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus). FDA's definition for product code OKO reads: "A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound...". FDA records list 7 510(k) clearances for Guard Medical, Inc., from to . As of , FDA records show no recalls naming K212971.

Clearance record

Decision date
Received
(146 days to decision)
Product code
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Regulation
21 CFR 878.4683
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Guard Medical, Inc. 1221 Brickwell Ave., Suite 900, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OKO

Trailing 12 months
1 clearance under product code OKO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OKO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260