Cleared Special

ULTIMA SMARTBELT, MODEL 0560 (K001743) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001743 · Braebon Medical Corp. · Anesthesiology device
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Aug 2000
Decision
78d
Days
Class 2
Risk

K001743 is an FDA 510(k) clearance for the ULTIMA SMARTBELT, MODEL 0560. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Braebon Medical Corp. (Carp, Ontario, CA). The FDA issued a Cleared decision on August 25, 2000 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Braebon Medical Corp. devices

Submission Details

510(k) Number K001743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2000
Decision Date August 25, 2000
Days to Decision 78 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
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 - BZQ Monitor, Breathing Frequency

All 35
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K001743.
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
K180079 · Hill-Rom, Inc. · May 2018
EarlySense Bed Sensing Unit
K171836 · Earlysense, Ltd. · Jan 2018
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · Ge Medical Systems Information Technologies · Mar 1997
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995