Cleared Abbreviated

K040605 - DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100

K040605 is an FDA 510(k) clearance for DYMEDIX REUSABLE RESPIRATORY EFFORT BEL..., manufactured by Dymedix, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Abbreviated 510(k) pathway after a 49-day FDA review.

K040605 · Dymedix, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
49d
Days
Class 2
Risk

K040605 is an FDA 510(k) clearance for the DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSA.... Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Dymedix, Inc. (Stoughton, US). The FDA issued a Cleared decision on April 26, 2004 after a review of 49 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. 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 - K040605

510(k) Number K040605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2004
Decision Date April 26, 2004
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Standards-based clearance path.

BZQ Device Classification - Class 2, Special Controls

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 160
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K040605.
EARLYSENSE ES-16 SYSTEM
K070375 · Earlysense, Ltd. · Nov 2007
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K062883 · Gereonics, Inc. · Jun 2007
ANDROFLOW - RESPIRATORY RATE MONITOR
K051779 · Andromed, Inc. · Sep 2005
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
K003704 · Optovent AB · Feb 2001
ULTIMA SMARTBELT, MODEL 0560
K001743 · Braebon Medical Corp. · Aug 2000
RESPIRATORY BELT SENSOR, MODEL 6000S
K001030 · Dymedix, Inc. · May 2000
K040605 · DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
Download PDF FDA Summary Dymedix, Inc.