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
K863578Substantially Equivalent for Some Indications

Dermatec Zone Transparent Dressing

Dermatec, Inc., Trumbull CT / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K863578 is the FDA 510(k) clearance record for DERMATEC ZONE TRANSPARENT DRESSING, a class I device, cleared for Dermatec, Inc. on under FDA product code NAD (Dressing, Wound, Occlusive). FDA records list 4 510(k) clearances for Dermatec, Inc., from to . As of , FDA records show no recalls naming K863578.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NAD Dressing, Wound, Occlusive
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dermatec, Inc. 91 Bunker Hill Dr., Trumbull CT
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