Cleared Abbreviated

Disposable Medical Surgical Mask (K201625) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K201625 · Tianjin Saiyuan Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
211d
Days
Class 2
Risk

K201625 is an FDA 510(k) clearance for the Disposable Medical Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tianjin Saiyuan Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on January 12, 2021 after a review of 211 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 Tianjin Saiyuan Technology Co., Ltd. devices

Submission Details

510(k) Number K201625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2020
Decision Date January 12, 2021
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
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 Consultant

Andon Health Co, Ltd.
Wang Yanhong

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 K201625.
Surgical Face Mask
K202904 · Jiangxi Feilikang Medical Technology Co., Ltd. · Jan 2021
Medical Protective Mask
K202107 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Jan 2021
Procedure face mask (Model: KKF-2A)
K202314 · Han Zhaoqing Sporting Goods Company Limited · Jan 2021
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
K202843 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Jan 2021
Medical Surgical Mask-Model MP002-5, MP002-6
K202577 · Jiangmen Sure&Me Medical Product Co., Ltd. · Jan 2021
Disposable Surgical Face Mask
K202491 · Jiangsu Newvalue Medical Products Co., Ltd. · Jan 2021