510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K203078Substantially Equivalent

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

Huizhou Tianchang Industrial Co., Ltd., Huizhou, CN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203078 is the FDA 510(k) clearance record for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW, a class II device, cleared for Huizhou Tianchang Industrial Co., Ltd. on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Huizhou Tianchang Industrial Co., Ltd. As of , FDA records show no recalls naming K203078.

Clearance record

Decision date
Received
(675 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Huizhou Tianchang Industrial Co., Ltd. #2 Xingde E. Rd., Dongjiang Hi-Tech Industrial Park,, Huizhou, CN
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