Cleared Special

K071556 - SOMNOSCREEN EEG10-20

K071556 is an FDA 510(k) clearance for SOMNOSCREEN EEG10-20, manufactured by Somnomedics GmbH. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 41-day FDA review.

K071556 · Somnomedics GmbH · Anesthesiology device
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Jul 2007
Decision
41d
Days
Class 2
Risk

K071556 is an FDA 510(k) clearance for the SOMNOSCREEN EEG10-20. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Somnomedics GmbH (Washington, US). The FDA issued a Cleared decision on July 18, 2007 after a review of 41 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 Somnomedics GmbH devices

FDA 510(k) Submission Details - K071556

510(k) Number K071556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2007
Decision Date July 18, 2007
Days to Decision 41 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
99d faster than avg
Panel avg: 140d · This submission: 41d
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 63
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