Cleared Traditional

Plain Surgical Mask (K201517) - FDA 510(k) Clearance

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

K201517 · Aok Tooling Limited · General Hospital
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Sep 2020
Decision
88d
Days
Class 2
Risk

K201517 is an FDA 510(k) clearance for the Plain Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Aok Tooling Limited (Shenzhen, CN). The FDA issued a Cleared decision on September 4, 2020 after a review of 88 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 Aok Tooling Limited devices

Submission Details

510(k) Number K201517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date September 04, 2020
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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

Aok Tooling Limited % Promedic, LLC
Paul Dryden

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 K201517.
Single-Use Surgical Mask With Ear Loop
K201691 · Qiqihar Hengxin Medical Supplies, Ltd. · Sep 2020
Disposable Medical Face Mask
K201470 · Jkh USA, LLC · Sep 2020
Surgical Mask-Model Number CW01
K202354 · Hunan Heng Chang Pharmaceutical Co., Ltd. · Sep 2020
Protective Face Mask for Medical Use
K201537 · Shandong Shengquan New Material Co., Ltd. · Sep 2020
Single-use Surgical Mask
K200923 · Byd Precision Manufacturer Co., Ltd. · Aug 2020
Motex Anti-Fog Surgical Face Mask
K201549 · Modern Healthcare Corp. · Aug 2020