Cleared Special

K202529 - ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

K202529 is an FDA 510(k) clearance for ProSomnus EVO Sleep and Snore Device, manufactured by Prosomnus Sleep Technologies, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 80-day FDA review.

K202529 · Prosomnus Sleep Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
80d
Days
Class 2
Risk

K202529 is an FDA 510(k) clearance for the ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device wi.... Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Prosomnus Sleep Technologies, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 20, 2020 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K202529

510(k) Number K202529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date November 20, 2020
Days to Decision 80 days
Submission Type Special
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
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 216
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K202529.
NOA Sleep Apnea and Snoring Device
K202651 · Orthoapnea S.L. · Feb 2021
Vital Sleep
K201719 · The Snore Reliever Company, LLC · Jan 2021
Somnos Anti-Snoring Mouth Guard
K201484 · Koncept Innovators, LLC · Nov 2020
Diamond Digital Sleep Orthotic (DDSO)
K202499 · Diamond Orthotic Laboratory · Sep 2020
Respire Pink AT (Hard, Hard/Soft, EF)
K192127 · Respire Medical Holdings · Feb 2020
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K193239 · Mpowrx Health and Wellness Products 2012, Inc. · Jan 2020
K202529 · ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
Download PDF FDA Summary Prosomnus Sleep Techn…