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
K831148Substantially Equivalent

High Filtration ISO-Mask

Tecnol New Jersey Wound Care, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831148 is the FDA 510(k) clearance record for HIGH FILTRATION ISO-MASK, a class II device, cleared for Tecnol New Jersey Wound Care, Inc. on under FDA product code FXX (Mask, Surgical). FDA records list 35 510(k) clearances for Tecnol New Jersey Wound Care, Inc., from to . As of , FDA records show 2 recalls naming K831148.

Clearance record

Decision date
Received
(466 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tecnol New Jersey Wound Care, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FXX

Trailing 12 months
8 clearances under product code FXX in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
November 20251
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260