510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K210063Substantially Equivalent

Freudenberg Surgical Mask

Freudenberg Performance Materials LP, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210063 is the FDA 510(k) clearance record for Freudenberg Surgical Mask, a class II device, cleared for Freudenberg Performance Materials LP on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Freudenberg Performance Materials LP. As of , FDA records show no recalls naming K210063.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Freudenberg Performance Materials LP 3500 Industrial Dr., Durham NC
510(k) summary
Summary PDF
Third party review
Yes

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