Cleared Special

K001866 - TCM400 (FDA 510(k) Clearance)

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

K001866 · Radiometer Medical A/S · Anesthesiology device
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Dec 2000
Decision
170d
Days
Class 2
Risk

K001866 is an FDA 510(k) clearance for the TCM400. Classified as Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia (product code LPP), Class II - Special Controls.

Submitted by Radiometer Medical A/S (Bronshoj, DK). The FDA issued a Cleared decision on December 7, 2000 after a review of 170 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radiometer Medical A/S devices

Submission Details

510(k) Number K001866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2000
Decision Date December 07, 2000
Days to Decision 170 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 139d · This submission: 170d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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.