Cleared Traditional

Banyan USA Surgical Mask Level 3 (K211097) - FDA 510(k) Clearance

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

K211097 · Banyan USA, LLC · General Hospital
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Sep 2021
Decision
162d
Days
Class 2
Risk

K211097 is an FDA 510(k) clearance for the Banyan USA Surgical Mask Level 3. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Banyan USA, LLC (Hauppauge, US). The FDA issued a Cleared decision on September 22, 2021 after a review of 162 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Banyan USA, LLC devices

Submission Details

510(k) Number K211097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2021
Decision Date September 22, 2021
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 Consultant

Mdi Consultants, Inc.
Timothy Kania

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 K211097.
Surgical Mask
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K210772 · Vr Vertical, LLC Dba Xrgo · Sep 2021
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
K203418 · Ningbo Ouhan Medical Device Co., Ltd. · Sep 2021
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Disposable Medical Mask
K203112 · Yangzhou Runyi Arts & Crafts Co., Ltd. · Sep 2021