Cleared Abbreviated

Surgical Face Mask (K201545) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K201545 · Amphastar Nanjing Pharmaceuticals, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2021
Decision
248d
Days
Class 2
Risk

K201545 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Amphastar Nanjing Pharmaceuticals, Inc. (Nanjing, CN). The FDA issued a Cleared decision on February 12, 2021 after a review of 248 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Amphastar Nanjing Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K201545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date February 12, 2021
Days to Decision 248 days
Submission Type Abbreviated
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
119d slower than avg
Panel avg: 129d · This submission: 248d
Pathway characteristics
Standards-based clearance path.

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 K201545.
iMask Disposable Surgical Face Mask
K201182 · Pac-Dent, Inc. · Feb 2021
Surgical Face Mask (non-sterile)
K203426 · Nantong Taiweishi Medical Technology Co., Ltd. · Feb 2021
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
K201732 · Dukal Corporation · Feb 2021
Disposable Surgical Mask
K202341 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Feb 2021
Standard Procedure Mask, Standard Surgical Mask
K202605 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · Feb 2021
nPro Surgical Mask
K203265 · Np Medical, Inc. · Feb 2021