Cleared Traditional

K191095 - Maxxi Snore Sensor

K191095 is an FDA 510(k) clearance for Maxxi Snore Sensor, manufactured by Neurovirtual USA, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K191095 · Neurovirtual USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
266d
Days
Class 2
Risk

K191095 is an FDA 510(k) clearance for the Maxxi Snore Sensor. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Neurovirtual USA, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on January 16, 2020 after a review of 266 days - an extended review cycle.

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 Neurovirtual USA, Inc. devices

FDA 510(k) Submission Details - K191095

510(k) Number K191095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2019
Decision Date January 16, 2020
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
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 K191095.
MATRx plus
K200695 · Zephyr Sleep Technologies · Aug 2020
Rubicon SA System
K200654 · Dymedix Diagnostics, Inc. · Jul 2020
NightOwl
K191031 · Ectosense NV · Mar 2020
MATRx Plus
K191925 · Zephyr Sleep Technologies · Oct 2019
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