Cleared Traditional

K181396 - Oral Device OA, Oral Device S

K181396 is an FDA 510(k) clearance for Oral Device OA, manufactured by Passion For Life Healthcare (Uk) Limited. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K181396 · Passion For Life Healthcare (Uk) Limited · Dental device
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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.

View all Passion For Life Healthcare (Uk) Limited devices

FDA 510(k) Submission Details - K181396

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 127d · This submission: 171d
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 167
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K181396.
SLEEPAPP
K182202 · Comfort Acrylics, Inc. · Jan 2019
Elevo® Kit Snoring Intervention Device
K181107 · Zelegent, Inc. · Dec 2018
ApnoDent Appliance
K181123 · Apnomed, Inc. · Nov 2018
myTAP2
K181482 · Airway Management, Inc. · Aug 2018
Advanced Dental Applicance
K172991 · Dasoft Partners · Jul 2018
Express 4 Sleep appliance/CPAP Sidekick appliance
K173856 · Moses Appliances, LLC · Jun 2018