Cleared Special

K111194 - APNEA RISK EVALUATION SYSTEM (ARES)

K111194 is an FDA 510(k) clearance for APNEA RISK EVALUATION SYSTEM (ARES), manufactured by Advanced Brain Monitoring, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 70-day FDA review.

K111194 · Advanced Brain Monitoring, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
70d
Days
Class 2
Risk

K111194 is an FDA 510(k) clearance for the APNEA RISK EVALUATION SYSTEM (ARES). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Waukesha, US). The FDA issued a Cleared decision on July 7, 2011 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111194

510(k) Number K111194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2011
Decision Date July 07, 2011
Days to Decision 70 days
Submission Type Special
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
70d faster than avg
Panel avg: 140d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 162
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K111194.
MORPHEUS OX
K111314 · Widemed, Ltd. · Aug 2011
MDRIVE
K111742 · Embla Systems · Aug 2011
ACCUSOM
K110486 · Novasom, Inc. · Aug 2011
WATCH-PAT 200S-3 (WP200S-3)
K102567 · Itamar Medical , Ltd. · Jun 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K110705 · Advanced Brain Monitoring, Inc. · Apr 2011
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K110064 · Snap Diagnostics, LLC · Mar 2011