Cleared Traditional

K181396 - Oral Device OA, Oral Device S (FDA 510(k) Clearance)

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

K181396 · Passion For Life Healthcare (Uk) Limited · Dental device
Nov 2018
Decision
171d
Days
Class 2
Risk

K181396 is an FDA 510(k) clearance for the Oral Device OA, Oral Device S. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Passion For Life Healthcare (Uk) Limited (Ellesmere Port, GB). The FDA issued a Cleared decision on November 16, 2018 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K181396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2018
Decision Date November 16, 2018
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 158d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K181396.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
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QuietLab Pro
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