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

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K060708.
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
CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · Cadwell Laboratories, Inc. · Nov 2006
SANDMAN POCKET
K061996 · Eb Neuro S.P.A. · Oct 2006
MEDIBYTE, MODEL MP8
K061764 · Braebon Medical Corp. · Sep 2006