Cleared Abbreviated

K043003 - TCM40 MONITORING SYSTEM (FDA 510(k) Clearance)

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

K043003 · Radiometer Medical Aps · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
120d
Days
Class 2
Risk

K043003 is an FDA 510(k) clearance for the TCM40 MONITORING SYSTEM. Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on March 1, 2005 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2480 - 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 Radiometer Medical Aps devices

Submission Details

510(k) Number K043003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date March 01, 2005
Days to Decision 120 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
19d faster than avg
Panel avg: 139d · This submission: 120d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LKD Monitor, Carbon-dioxide, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2480
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.