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
K212302Substantially Equivalent

BAYLAB 3-Ply Surgical Mask (BEACON I)

Baylab USA, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212302 is the FDA 510(k) clearance record for BAYLAB 3-Ply Surgical Mask (BEACON I), a class II device, cleared for Baylab USA, LLC on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Baylab USA, LLC. As of , FDA records show no recalls naming K212302.

Clearance record

Decision date
Received
(137 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Baylab USA, LLC 2230 Lyndon B Johnson Fwy., Suite 100, Dallas TX
510(k) summary
Summary PDF
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