Cleared Abbreviated

K001030 - RESPIRATORY BELT SENSOR, MODEL 6000S

Also marketed or referenced as:
LIMB MOVEMENT SENSOR, MODEL 3000S

K001030 is an FDA 510(k) clearance for RESPIRATORY BELT SENSOR, 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 42-day FDA review.

K001030 · Dymedix, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
42d
Days
Class 2
Risk

K001030 is an FDA 510(k) clearance for the RESPIRATORY BELT SENSOR, MODEL 6000S. 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 May 11, 2000 after a review of 42 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 - K001030

510(k) Number K001030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date May 11, 2000
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
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 K001030.
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
K040605 · Dymedix, Inc. · Apr 2004
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
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411 · Gereonics, Inc. · Apr 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K983449 · Gereonics, Inc. · Feb 1999
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K981725 · Optovent, Inc. · Feb 1999
K001030 · RESPIRATORY BELT SENSOR, MODEL 6000S
Download PDF FDA Summary Dymedix, Inc.