Cleared Abbreviated

American-Made Surgical Mask (K210101) - FDA 510(k) Clearance

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

K210101 · Armbrust, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
377d
Days
Class 2
Risk

K210101 is an FDA 510(k) clearance for the American-Made Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Armbrust, Inc. (Pflugerville, US). The FDA issued a Cleared decision on January 26, 2022 after a review of 377 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 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 Armbrust, Inc. devices

Submission Details

510(k) Number K210101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2021
Decision Date January 26, 2022
Days to Decision 377 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
248d slower than avg
Panel avg: 129d · This submission: 377d
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 K210101.
Surgical Face Mask
K212863 · Taiwan Comfort Champ Manufacturing Co., Ltd. · Feb 2022
Surgical Face Mask
K213617 · Megasoft (China) Co., Ltd. · Feb 2022
Surgical Masks
K212120 · Hubei Xinxin Non-Woven Co., Ltd. · Jan 2022
Surgical Face Mask
K212610 · Foshan Nanhai Plus Medical Co, Ltd. · Jan 2022
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