Cleared Abbreviated

K043003 - TCM40 MONITORING SYSTEM

K043003 is an FDA 510(k) clearance for TCM40 MONITORING SYSTEM, manufactured by Radiometer Medical Aps. The device is a Class 2 Anesthesiology device with product code LKD cleared through the Abbreviated 510(k) pathway after a 120-day FDA review.

K043003 · Radiometer Medical Aps · Anesthesiology device
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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

FDA 510(k) Submission Details - K043003

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Standards-based clearance path.

LKD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LKD Monitor, Carbon-dioxide, Cutaneous

All 8
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