Cleared Traditional

K200923 - Single-use Surgical Mask

K200923 is the FDA 510(k) clearance for Single-use Surgical Mask by Byd Precision Manufacturer Co., Ltd.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K200923 · Byd Precision Manufacturer Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
141d
Days
Class 2
Risk

K200923 is an FDA 510(k) clearance for the Single-use Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Byd Precision Manufacturer Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 26, 2020 after a review of 141 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 Byd Precision Manufacturer Co., Ltd. devices

Submission Details

510(k) Number K200923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2020
Decision Date August 26, 2020
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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

Nova Clinical Solutions, Inc.
Annie Zhang

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 436
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K200923.
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
Motex Anti-Fog Surgical Face Mask
K201549 · Modern Healthcare Corp. · Aug 2020
Asept Surgical Face Mask
K201137 · Pfm Medical, Inc. · Aug 2020
Surgical Mask
K201871 · C & S Paper Yunfu Co., Ltd. · Aug 2020