Cleared Special

K111742 - MDRIVE

K111742 is an FDA 510(k) clearance for MDRIVE, manufactured by Embla Systems. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 71-day FDA review.

K111742 · Embla Systems · Anesthesiology device
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Aug 2011
Decision
71d
Days
Class 2
Risk

K111742 is an FDA 510(k) clearance for the MDRIVE. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Embla Systems (Thornton, US). The FDA issued a Cleared decision on August 31, 2011 after a review of 71 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.

View all Embla Systems devices

FDA 510(k) Submission Details - K111742

510(k) Number K111742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date August 31, 2011
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
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 109
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K111742.
SLEEPSTRIP II
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MICHELE SLEEP SCORING SYSTEMS
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MORPHEUS OX
K111314 · Widemed, Ltd. · Aug 2011
ACCUSOM
K110486 · Novasom, Inc. · Aug 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K111194 · Advanced Brain Monitoring, Inc. · Jul 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K110705 · Advanced Brain Monitoring, Inc. · Apr 2011