← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FXX — Mask, Surgical

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4040
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K251967O&M Halyard, Inc. · 510k2026-03-18
K252534Zhejiang Hangkang Medical Equipment Co., Ltd. · 510k2026-03-03
K253398Efofex, Inc. · 510k2026-02-19
K252830Beatles Medical Supplies (Xiantao) Co., Ltd. · 510k2026-01-12
K252650Makrite Industries, Inc. · 510k2026-01-05
K243342Kp Trading Co., Ltd. · 510k2025-12-22
K252941O&M Halyard, Inc. · 510k2025-12-11
K252964Primed Medical Products, Inc. · 510k2025-11-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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