Cleared Traditional

K201470 - Disposable Medical Face Mask

K201470 is an FDA 510(k) clearance for Disposable Medical Face Mask, manufactured by Jkh USA, LLC. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K201470 · Jkh USA, LLC · General Hospital
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Sep 2020
Decision
97d
Days
Class 2
Risk

K201470 is an FDA 510(k) clearance for the Disposable Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Jkh USA, LLC (Walnut, US). The FDA issued a Cleared decision on September 8, 2020 after a review of 97 days - within the typical 510(k) review window.

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 Jkh USA, LLC devices

FDA 510(k) Submission Details - K201470

510(k) Number K201470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2020
Decision Date September 08, 2020
Days to Decision 97 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K201470.
Surgical Face Mask
K202277 · Jiangxi 3l Medical Products Group Co., Ltd. · Sep 2020
Disposable Surgical Mask
K202463 · Unisources Group, LLC · Sep 2020
Single-Use Surgical Mask With Ear Loop
K201691 · Qiqihar Hengxin Medical Supplies, Ltd. · Sep 2020
Surgical Mask-Model Number CW01
K202354 · Hunan Heng Chang Pharmaceutical Co., Ltd. · Sep 2020
Plain Surgical Mask
K201517 · Aok Tooling Limited · Sep 2020
Protective Face Mask for Medical Use
K201537 · Shandong Shengquan New Material Co., Ltd. · Sep 2020