Cleared Traditional

K191925 - MATRx Plus

K191925 is the FDA 510(k) clearance for MATRx Plus by Zephyr Sleep Technologies. It is a Class 2 Dental device (product code MNR) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K191925 · Zephyr Sleep Technologies · Dental device
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Oct 2019
Decision
103d
Days
Class 2
Risk

K191925 is an FDA 510(k) clearance for the MATRx Plus. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Zephyr Sleep Technologies (Calgary, CA). The FDA issued a Cleared decision on October 29, 2019 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 868.2375 - 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 Zephyr Sleep Technologies devices

Submission Details

510(k) Number K191925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2019
Decision Date October 29, 2019
Days to Decision 103 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 faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - MNR Ventilatory Effort Recorder

All 60
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K191925.
Rubicon SA System
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NightOwl
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Maxxi Snore Sensor
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SomnaPatch
K183625 · Respironics, Inc. · Oct 2019
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
K180001 · Embla Systems · Sep 2019
SleepImage System
K182618 · Mycardio, LLC Dba Sleepimage. · Aug 2019