Cleared Traditional

K012437 - DEVILBISS SLEEP RECORDER MODEL # RM60

K012437 is an FDA 510(k) clearance for DEVILBISS SLEEP RECORDER MODEL # RM60, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K012437 · Sunrise Medical Hhg, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
350d
Days
Class 2
Risk

K012437 is an FDA 510(k) clearance for the DEVILBISS SLEEP RECORDER MODEL # RM60. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Sunrise Medical Hhg, Inc. (Somerset, US). The FDA issued a Cleared decision on July 16, 2002 after a review of 350 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 - K012437

510(k) Number K012437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2001
Decision Date July 16, 2002
Days to Decision 350 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
210d slower than avg
Panel avg: 140d · This submission: 350d
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 164
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K012437.
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K002159 · Sagatech Electronics, Inc. · Jun 2002
SLEEP PAT 200 DEVICE
K010156 · Itamar Medical (C.M.) 1997 , Ltd. · Jun 2002
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
K013905 · Pro-Tech Services, Inc. · Apr 2002
K012437 · DEVILBISS SLEEP RECORDER MODEL # RM60
Download PDF FDA Summary Sunrise Medical Hhg, …