Cleared Abbreviated

K020607 - SLEEPFLO, MODEL 101501

K020607 is an FDA 510(k) clearance for SLEEPFLO, manufactured by Biomec, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Abbreviated 510(k) pathway after a 186-day FDA review.

K020607 · Biomec, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
186d
Days
Class 2
Risk

K020607 is an FDA 510(k) clearance for the SLEEPFLO, MODEL 101501. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Biomec, Inc. (Cleveland, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 186 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K020607

510(k) Number K020607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2002
Decision Date August 30, 2002
Days to Decision 186 days
Submission Type Abbreviated
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
46d slower than avg
Panel avg: 140d · This submission: 186d
Pathway characteristics
Standards-based clearance path.

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 K020607.
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
K030611 · Nellcor Puritan Bennett (Melville) , Ltd. · Mar 2003
SLEEPSCREEN/APNOESCREEN CARDIO
K021138 · Erich Jaeger GmbH · Feb 2003
COMPUMEDICS SOMTE SYSTEM
K021176 · Compumedics Limited · Jan 2003
ULTIMA SNORING MIKE, MODEL 0540
K020312 · Braebon Medical Corp. · 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
K020607 · SLEEPFLO, MODEL 101501
Download PDF FDA Summary Biomec, Inc.