Cleared Traditional

K021176 - COMPUMEDICS SOMTE SYSTEM

K021176 is an FDA 510(k) clearance for COMPUMEDICS SOMTE SYSTEM, manufactured by Compumedics Limited. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K021176 · Compumedics Limited · Anesthesiology device
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Jan 2003
Decision
284d
Days
Class 2
Risk

K021176 is an FDA 510(k) clearance for the COMPUMEDICS SOMTE SYSTEM. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Compumedics Limited (Minneapolis,, US). The FDA issued a Cleared decision on January 21, 2003 after a review of 284 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. 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. Standard predicate reliance. 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 Compumedics Limited devices

FDA 510(k) Submission Details - K021176

510(k) Number K021176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2002
Decision Date January 21, 2003
Days to Decision 284 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
144d slower than avg
Panel avg: 140d · This submission: 284d
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 151
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K021176.
COMPASS F10 SYSTEM
K041904 · Medcare Flaga · Sep 2004
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
SLEEPSCREEN/APNOESCREEN CARDIO
K021138 · Erich Jaeger GmbH · Feb 2003
SLEEPFLO, MODEL 101501
K020607 · Biomec, Inc. · Aug 2002
ULTIMA SNORING MIKE, MODEL 0540
K020312 · Braebon Medical Corp. · Aug 2002
DEVILBISS SLEEP RECORDER MODEL # RM60
K012437 · Sunrise Medical Hhg, Inc. · Jul 2002