Cleared Traditional

Surgical Face Mask (K203161) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203161 · Wuhan Raytex Protection Co., Ltd. · General Hospital
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Jan 2022
Decision
454d
Days
Class 2
Risk

K203161 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Wuhan Raytex Protection Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on January 20, 2022 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Wuhan Raytex Protection Co., Ltd. devices

Submission Details

510(k) Number K203161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2020
Decision Date January 20, 2022
Days to Decision 454 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 129d · This submission: 454d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K203161.
ADI Medical Surgical Face Mask
K213347 · Asia Dynamics Inc., D/B/A Adi Medical · Jan 2022
Myflon Surgical Mask Level 3
K212111 · Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi · Jan 2022
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
K213970 · Danameco Medical Joint Stock Corporation · Jan 2022
Disposable Medical Mask
K212826 · Jiangsu Nanfang Medical Co., Ltd. · Jan 2022
Medical Face Mask
K210679 · Wuxi Yushou Medical Appliances Co., Ltd. · Jan 2022
Medical Face Mask
K212994 · Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. · Jan 2022