Cleared Traditional

Surgical Face Mask (K210225) - FDA 510(k) Clearance

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

K210225 · Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. · General Hospital
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Mar 2021
Decision
35d
Days
Class 2
Risk

K210225 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 4, 2021 after a review of 35 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 Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. devices

Submission Details

510(k) Number K210225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2021
Decision Date March 04, 2021
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K210225.
Single-use medical face mask
K201974 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Mar 2021
Surgical Mask
K203425 · Bdc Dental Corporation , Ltd. · Mar 2021
Disposable medical mask
K202137 · U-Play Products Corporation · Mar 2021
Medical mask (Model: KKF-1A)
K202316 · Han Zhaoqing Sporting Goods Company Limited · Mar 2021
Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K201852 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2021
IFM Surgical Mask Model SM3
K202214 · Fssc, LLC · Mar 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.