510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K885325Substantially Equivalent for Some Indications

Frastec Conformant Dressing, Various Sizes

Frastec Wound Care Products, Inc., Bronx NY / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K885325 is the FDA 510(k) clearance record for FRASTEC CONFORMANT DRESSING, VARIOUS SIZES, a class I device, cleared for Frastec Wound Care Products, Inc. on under FDA product code NAD (Dressing, Wound, Occlusive). FDA records list one 510(k) clearance for Frastec Wound Care Products, Inc. As of , FDA records show no recalls naming K885325.

Clearance record

Decision date
Received
(110 days to decision)
Product code
NAD Dressing, Wound, Occlusive
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Frastec Wound Care Products, Inc. 3830 Boston Rd., Bronx NY
Third party review
No

Clearances, product code NAD

Trailing 12 months
1 clearance under product code NAD 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 NAD, 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