Cleared Traditional

K202651 - NOA Sleep Apnea and Snoring Device

K202651 is an FDA 510(k) clearance for NOA Sleep Apnea and Snoring Device, manufactured by Orthoapnea S.L.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K202651 · Orthoapnea S.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
151d
Days
Class 2
Risk

K202651 is an FDA 510(k) clearance for the NOA Sleep Apnea and Snoring Device. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Orthoapnea S.L. (Malaga, ES). The FDA issued a Cleared decision on February 12, 2021 after a review of 151 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 Orthoapnea S.L. devices

FDA 510(k) Submission Details - K202651

510(k) Number K202651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2020
Decision Date February 12, 2021
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
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 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K202651.
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
K203606 · Meris Investment Group · Mar 2021
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K203477 · Orthoapnea S.L. · Feb 2021
Advanced Dental Appliance
K203462 · Dasoft Partners · Feb 2021
Vital Sleep
K201719 · The Snore Reliever Company, LLC · Jan 2021
Somnos Anti-Snoring Mouth Guard
K201484 · Koncept Innovators, LLC · Nov 2020
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
K202529 · Prosomnus Sleep Technologies, Inc. · Nov 2020