Cleared Traditional

K060708 - SOMNOSCREEN

K060708 is an FDA 510(k) clearance for SOMNOSCREEN, manufactured by Somnomedics GmbH & Co. KG. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K060708 · Somnomedics GmbH & Co. KG · Anesthesiology device
Download Printable Device Report (PDF)
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Jan 2007
Decision
314d
Days
Class 2
Risk

K060708 is an FDA 510(k) clearance for the SOMNOSCREEN. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Somnomedics GmbH & Co. KG (Washington, US). The FDA issued a Cleared decision on January 24, 2007 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Somnomedics GmbH & Co. KG devices

FDA 510(k) Submission Details - K060708

510(k) Number K060708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2006
Decision Date January 24, 2007
Days to Decision 314 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 140d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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STARDUST II
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BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · Salter Labs · Sep 2005