Cleared Traditional

K993381 - TONGUE STABILIZER DEVICE

K993381 is an FDA 510(k) clearance for TONGUE STABILIZER DEVICE, manufactured by University of Otago. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K993381 · University of Otago · Dental device
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Dec 1999
Decision
75d
Days
Class 2
Risk

K993381 is an FDA 510(k) clearance for the TONGUE STABILIZER DEVICE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by University of Otago (Tonawanda, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory 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 University of Otago devices

FDA 510(k) Submission Details - K993381

510(k) Number K993381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1999
Decision Date December 21, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 Dental devices follow this clearance model.

Regulatory Peers - LRK Device, Anti-snoring

All 112
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