Cleared Traditional

K203376 - ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G (FDA 510(k) Clearance)

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

K203376 · Medtecs (Taiwan) Corp. · General Hospital
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Mar 2022
Decision
470d
Days
Class 2
Risk

K203376 is an FDA 510(k) clearance for the ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: F.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Medtecs (Taiwan) Corp. (Taipei City, TW). The FDA issued a Cleared decision on March 2, 2022 after a review of 470 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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 Medtecs (Taiwan) Corp. devices

Submission Details

510(k) Number K203376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2020
Decision Date March 02, 2022
Days to Decision 470 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
342d slower than avg
Panel avg: 128d · This submission: 470d
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

Jin Services Co.
Sandy Liu

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

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