Cleared Traditional

K181996 - MATRx Plus

K181996 is an FDA 510(k) clearance for MATRx Plus, manufactured by Zephyr Sleep Technologies. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K181996 · Zephyr Sleep Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
118d
Days
Class 2
Risk

K181996 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 November 21, 2018 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zephyr Sleep Technologies devices

FDA 510(k) Submission Details - K181996

510(k) Number K181996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2018
Decision Date November 21, 2018
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

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 Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 109
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K181996.
Maxxi Rip Sensor
K171304 · Neurovirtual USA, Inc. · Jun 2019
WatchPAT ONE
K183559 · Itamar Medical , Ltd. · Jun 2019
XactTrace Single Use Respiratory Effort Belt System
K173793 · Embla Systems · Mar 2019
Watch-PAT300
K180775 · Itamar Medical , Ltd. · Aug 2018
Positional Sleep Assessment System (PoSAS) software
K172799 · Advanced Brain Monitoring · Mar 2018
SleepImage System
K163696 · Mycardio, LLC Dba Sleepimage. · Oct 2017