Cleared Traditional

K842461 - TONGUE DEPRESSOR

K842461 is an FDA 510(k) clearance for TONGUE DEPRESSOR, manufactured by The Torrent Corp.. The device is a Class 1 General Hospital device with product code FMA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K842461 · The Torrent Corp. · General Hospital
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Nov 1984
Decision
161d
Days
Class 1
Risk

K842461 is an FDA 510(k) clearance for the TONGUE DEPRESSOR. Classified as Depressor, Tongue, Non-surgical (product code FMA), Class I - General Controls.

Submitted by The Torrent Corp. (Walker, US). The FDA issued a Cleared decision on November 30, 1984 after a review of 161 days - an extended review cycle.

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 The Torrent Corp. devices

FDA 510(k) Submission Details - K842461

510(k) Number K842461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date November 30, 1984
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

FMA Device Classification - Class 1, General Controls

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.