Cleared Special

K071230 - APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600

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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K071230.
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
K072201 · Compumedics Limited · Apr 2008
SLEEP QUALITY
K070855 · Dynadx Corporation · Mar 2008
VITASCORE
K072014 · Vitascore B.V. · Nov 2007
SOMNOSCREEN EEG10-20
K071556 · Somnomedics GmbH · Jul 2007
APNEALINK
K070263 · Resmed Germany, Inc. · Jun 2007
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
K070326 · Widemed, Ltd. · May 2007