Cleared Traditional

ASM-301 Level 3 Surgical Mask (K211440) - FDA 510(k) Clearance

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

K211440 · American Surgical Mask Company, LLC · General Hospital
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Jun 2021
Decision
23d
Days
Class 2
Risk

K211440 is an FDA 510(k) clearance for the ASM-301 Level 3 Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by American Surgical Mask Company, LLC (Tampa, US). The FDA issued a Cleared decision on June 2, 2021 after a review of 23 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.

View all American Surgical Mask Company, LLC devices

Submission Details

510(k) Number K211440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2021
Decision Date June 02, 2021
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K211440.
Surgical Face Mask
K203190 · Rfx+Care Manufactoring Co., Ltd. · Jun 2021
Disposable Medical mask
K210150 · Hubei Wanli Protective Products Co., Ltd. · Jun 2021
Disposable Surgical Face Mask
K210429 · Jiangxi Heying Pharmaceutical Co., Ltd. · Jun 2021
AirMax Procedure Mask
K211275 · Premiumestore, LLC · May 2021
Procedure Mask, Surgical Mask
K202899 · Kenpax International Limited · May 2021
Ear-Friendly Mask
K211105 · Ray Co., Ltd. · May 2021

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.