Cleared Abbreviated

PMW01 Procedure Mask Level 1 (K211772) - FDA 510(k) Clearance

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

K211772 · Defender Safety, Inc. · General Hospital
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Dec 2021
Decision
181d
Days
Class 2
Risk

K211772 is an FDA 510(k) clearance for the PMW01 Procedure Mask Level 1. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Defender Safety, Inc. (Plainview, US). The FDA issued a Cleared decision on December 6, 2021 after a review of 181 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 Defender Safety, Inc. devices

Submission Details

510(k) Number K211772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2021
Decision Date December 06, 2021
Days to Decision 181 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K211772.
Medical Surgical Mask
K212867 · Nanchang Kanghua Health Materials Co., Ltd. · Dec 2021
MAF Guard
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BAYLAB 3-Ply Surgical Mask (BEACON I)
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Surgical Face Mask
K212235 · Shanghai Yunqing Industrial Co., Ltd. · Dec 2021
Surgical Masks
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Single-use Surgical Mask
K211773 · Taiwan Seafood and Fish Corporation · Dec 2021