Cleared Traditional

Surgical Mask (K211497) - FDA 510(k) Clearance

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

K211497 · Honeywell Safety Products · General Hospital
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Jul 2021
Decision
75d
Days
Class 2
Risk

K211497 is an FDA 510(k) clearance for the Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Honeywell Safety Products (Smithfield, US). The FDA issued a Cleared decision on July 28, 2021 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K211497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2021
Decision Date July 28, 2021
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 K211497.
MEO Med Disposable Medical Face Mask
K210870 · Fujian Meo Medical Technology Limited · Jul 2021
Disposable Surgical Face Mask
K210409 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Jul 2021
Purism Disposable Surgical Mask
K210856 · Chuzhou Daddy'S Choice Science and Technology Co., Ltd. · Jul 2021
TAIJI Professional Series Level 3 Surgical Face Mask
K211861 · Taiji Medical Supplies, Inc. · Jul 2021
MASC Surgical Mask
K211984 · Mid-America Safety Corp. · Jul 2021
Medical Face Mask
K211363 · Hubei Kangning Protective Products Co., Ltd. · Jul 2021