Cleared Traditional

K191095 - Maxxi Snore Sensor

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

K191095 · Neurovirtual USA, Inc. · Anesthesiology device
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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

Submission Details

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.

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 Anesthesiology devices follow this clearance model.

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All 60
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