Cleared Special

K192127 - Respire Pink AT (Hard, Hard/Soft, EF)

K192127 is an FDA 510(k) clearance for Respire Pink AT (Hard, manufactured by Respire Medical Holdings. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 183-day FDA review.

K192127 · Respire Medical Holdings · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
183d
Days
Class 2
Risk

K192127 is an FDA 510(k) clearance for the Respire Pink AT (Hard, Hard/Soft, EF). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Respire Medical Holdings (Brooklyn, US). The FDA issued a Cleared decision on February 5, 2020 after a review of 183 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. 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. Standard predicate reliance. 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 - K192127

510(k) Number K192127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2019
Decision Date February 05, 2020
Days to Decision 183 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
55d slower than avg
Panel avg: 128d · This submission: 183d
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 K192127.
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
Diamond Digital Sleep Orthotic (DDSO)
K202499 · Diamond Orthotic Laboratory · Sep 2020
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K193239 · Mpowrx Health and Wellness Products 2012, Inc. · Jan 2020
SleepTight Mouthpiece STZ
K191618 · Michael D Williams Dds PA · Dec 2019
Sapphire Dorsal Comfort Fit
K181416 · Crane Dental Laboratory, Inc. · Sep 2019
K192127 · Respire Pink AT (Hard, Hard/Soft, EF)
Download PDF FDA Summary Respire Medical Holdi…