Cleared Traditional

TOP WHOLESOME FACE MASK (K984389) - FDA 510(k) Clearance

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

K984389 · Top Wholesome Enterprise Co., Ltd. · General Hospital
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Apr 1999
Decision
122d
Days
Class 2
Risk

K984389 is an FDA 510(k) clearance for the TOP WHOLESOME FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Top Wholesome Enterprise Co., Ltd. (Bangna, TH). The FDA issued a Cleared decision on April 9, 1999 after a review of 122 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 Top Wholesome Enterprise Co., Ltd. devices

Submission Details

510(k) Number K984389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date April 09, 1999
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
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 Peers - FXX Mask, Surgical

All 401
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K984389.
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