Cleared Abbreviated

K203078 - CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW (FDA 510(k) Clearance)

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

K203078 · Huizhou Tianchang Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
675d
Days
Class 2
Risk

K203078 is an FDA 510(k) clearance for the CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Huizhou Tianchang Industrial Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on August 19, 2022 after a review of 675 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Huizhou Tianchang Industrial Co., Ltd. devices

Submission Details

510(k) Number K203078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date August 19, 2022
Days to Decision 675 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
547d slower than avg
Panel avg: 128d · This submission: 675d
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

Mhetra, LLC
Viky Verna

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 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K203078.
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops
K251967 · O&M Halyard, Inc. · Mar 2026
Surgical Face Mask (Ear mount)
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · Efofex, Inc. · Feb 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 2026
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025