Cleared Traditional

K020312 - ULTIMA SNORING MIKE, MODEL 0540

K020312 is an FDA 510(k) clearance for ULTIMA SNORING MIKE, manufactured by Braebon Medical Corp.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K020312 · Braebon Medical Corp. · Anesthesiology device
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Aug 2002
Decision
189d
Days
Class 2
Risk

K020312 is an FDA 510(k) clearance for the ULTIMA SNORING MIKE, MODEL 0540. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Braebon Medical Corp. (Carp, Ontario, CA). The FDA issued a Cleared decision on August 7, 2002 after a review of 189 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.

FDA 510(k) Submission Details - K020312

510(k) Number K020312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2002
Decision Date August 07, 2002
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
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 K020312.
SLEEPSCREEN/APNOESCREEN CARDIO
K021138 · Erich Jaeger GmbH · Feb 2003
COMPUMEDICS SOMTE SYSTEM
K021176 · Compumedics Limited · Jan 2003
SLEEPFLO, MODEL 101501
K020607 · Biomec, Inc. · Aug 2002
DEVILBISS SLEEP RECORDER MODEL # RM60
K012437 · Sunrise Medical Hhg, Inc. · Jul 2002
SNORE SAT RECORDER, MODEL SS41
K002159 · Sagatech Electronics, Inc. · Jun 2002
SLEEP PAT 200 DEVICE
K010156 · Itamar Medical (C.M.) 1997 , Ltd. · Jun 2002