510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K254160Substantially Equivalent

VacHeal Negative Pressure Wound Therapy System

VacHeal, LLC, Ardmore PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(270 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
VacHeal, LLC 40 E. Montgomery Ave., Ardmore PA
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