510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942476Substantially Equivalent

Protectaide Biohazard Clean-Up Kit No. B3069

Protectaide, Inc., Rockwall TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942476 is the FDA 510(k) clearance record for PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069, a class II device, cleared for Protectaide, Inc. on under FDA product code FXX (Mask, Surgical). FDA records list 11 510(k) clearances for Protectaide, Inc., from to . As of , FDA records show no recalls naming K942476.

Clearance record

Decision date
Received
(146 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Protectaide, Inc. 605 White Hills Dr., Rockwall TX
510(k) summary
Statement
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