Cleared Special

K071230 - APNEA RISK EVALUATION SYSTEM (ARES)

K071230 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 153-day FDA review.

K071230 · Advanced Brain Monitoring, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Oct 2007
Decision
153d
Days
Class 2
Risk

K071230 is an FDA 510(k) clearance for the APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 3, 2007 after a review of 153 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Brain Monitoring, Inc. devices

FDA 510(k) Submission Details - K071230

510(k) Number K071230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date October 03, 2007
Days to Decision 153 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 140d · This submission: 153d
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 65
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K071230.
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STARDUST II
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BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · Salter Labs · Sep 2005