Cleared Traditional

HYPNOSPAD (K152660) - FDA 510(k) Clearance

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

K152660 · Somnics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
419d
Days
Class 2
Risk

K152660 is an FDA 510(k) clearance for the HYPNOSPAD. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Somnics, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on November 9, 2016 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Somnics, Inc. devices

Submission Details

510(k) Number K152660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2015
Decision Date November 09, 2016
Days to Decision 419 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
292d slower than avg
Panel avg: 127d · This submission: 419d
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 81
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K152660.
REST EAZY Appliance
K172760 · Insert Molding Solutions, Inc. · Mar 2018
The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018
Snorer's Friend
K171529 · Scope Healthcare Technologies Pty, Ltd. · Jan 2018
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K070327 · Sybron Dental Specialties, Inc. · May 2007
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004