Cleared Traditional

K992995 - AROMATIC AND FLAVORED TONGUE DEPRESSOR (FDA 510(k) Clearance)

Class I General Hospital device.

K992995 · Aga Plastic Ind. Com. Ltda. · General Hospital
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Dec 1999
Decision
93d
Days
Class 1
Risk

K992995 is an FDA 510(k) clearance for the AROMATIC AND FLAVORED TONGUE DEPRESSOR. Classified as Depressor, Tongue, Non-surgical (product code FMA), Class I - General Controls.

Submitted by Aga Plastic Ind. Com. Ltda. (Great Neck, US). The FDA issued a Cleared decision on December 9, 1999 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6230 - 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 Aga Plastic Ind. Com. Ltda. devices

Submission Details

510(k) Number K992995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date December 09, 1999
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 128d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMA Depressor, Tongue, Non-surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6230
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.