Cleared Traditional

K031353 - SOLUTION FACE MASKS (FDA 510(k) Clearance)

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

K031353 · A Plus International, Inc. · General Hospital
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Jun 2003
Decision
51d
Days
Class 2
Risk

K031353 is an FDA 510(k) clearance for the SOLUTION FACE MASKS. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by A Plus International, Inc. (Chino, US). The FDA issued a Cleared decision on June 19, 2003 after a review of 51 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 A Plus International, Inc. devices

Submission Details

510(k) Number K031353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2003
Decision Date June 19, 2003
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 128d · This submission: 51d
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 Peers - FXX Mask, Surgical

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