Cleared Abbreviated

K201852 - Surgical Mask-Model Number: Ear Loop

K201852 is the FDA 510(k) clearance for Surgical Mask-Model Number: Ear Loop by Huizhou Foryou Medical Devices Co., Ltd.. It is a Class 2 General Hospital device (product code FXX) cleared through the Abbreviated 510(k) pathway after a 239-day FDA review.

K201852 · Huizhou Foryou Medical Devices Co., Ltd. · General Hospital
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Mar 2021
Decision
239d
Days
Class 2
Risk

K201852 is an FDA 510(k) clearance for the Surgical Mask-Model Number: Ear Loop, Flat-Pleated. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on March 2, 2021 after a review of 239 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Huizhou Foryou Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K201852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2020
Decision Date March 02, 2021
Days to Decision 239 days
Submission Type Abbreviated
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
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Standards-based clearance path.

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 436
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