Cleared Traditional

K161980 - Fuselier Intraoral Nighttime Device (FIND)

K161980 is an FDA 510(k) clearance for Fuselier Intraoral Nighttime Device (FIND), manufactured by Fuselier Enterprises, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K161980 · Fuselier Enterprises, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
204d
Days
Class 2
Risk

K161980 is an FDA 510(k) clearance for the Fuselier Intraoral Nighttime Device (FIND). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Fuselier Enterprises, LLC (Maitland, US). The FDA issued a Cleared decision on February 7, 2017 after a review of 204 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.

FDA 510(k) Submission Details - K161980

510(k) Number K161980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date February 07, 2017
Days to Decision 204 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
76d slower than avg
Panel avg: 128d · This submission: 204d
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 207
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K161980.
O2Vent W
K171316 · Oventus Manufacturing Pty, Ltd. · Jul 2017
ASD Oral Appliances
K163580 · American Sleep Dentistry · Jun 2017
Respire Pink Series with DentiTrac
K170692 · Respire Medical Holding · May 2017
BluePro
K162192 · Bluesom · Dec 2016
HYPNOSPAD
K152660 · Somnics, Inc. · Nov 2016
O2VENT T
K161832 · Oventus Manufacturing Pty, Ltd. · Sep 2016