Cleared Abbreviated

K001030 - RESPIRATORY BELT SENSOR, MODEL 6000S (FDA 510(k) Clearance)

Also includes:
LIMB MOVEMENT SENSOR, MODEL 3000S

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

K001030 · Dymedix, Inc. · Anesthesiology device
Download Printable Device Report (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.

View all Dymedix, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 139d · This submission: 42d
Pathway characteristics
Standards-based clearance path.

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 173
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