Cleared Traditional

K171304 - Maxxi Rip Sensor

K171304 is the FDA 510(k) clearance for Maxxi Rip Sensor by Neurovirtual USA, Inc.. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 782-day FDA review.

K171304 · Neurovirtual USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
782d
Days
Class 2
Risk

K171304 is an FDA 510(k) clearance for the Maxxi Rip Sensor. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Neurovirtual USA, Inc. (Doral, US). The FDA issued a Cleared decision on June 24, 2019 after a review of 782 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Neurovirtual USA, Inc. devices

Submission Details

510(k) Number K171304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2017
Decision Date June 24, 2019
Days to Decision 782 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
642d slower than avg
Panel avg: 140d · This submission: 782d
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.

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 K171304.
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
DROWZLE
K173974 · Resonea, Inc. · Jul 2019
WatchPAT ONE
K183559 · Itamar Medical , Ltd. · Jun 2019
XactTrace Single Use Respiratory Effort Belt System
K173793 · Embla Systems · Mar 2019
MATRx Plus
K181996 · Zephyr Sleep Technologies · Nov 2018