Cleared Special

K003943 - MICROGAS 7650 TRANSCUTANEOUS MONITOR (FDA 510(k) Clearance)

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

K003943 · Linde Medical Sensors AG · Anesthesiology device
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May 2001
Decision
134d
Days
Class 2
Risk

K003943 is an FDA 510(k) clearance for the MICROGAS 7650 TRANSCUTANEOUS MONITOR. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Linde Medical Sensors AG (Basel, CH). The FDA issued a Cleared decision on May 4, 2001 after a review of 134 days - within the typical 510(k) review window.

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 Linde Medical Sensors AG devices

Submission Details

510(k) Number K003943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2000
Decision Date May 04, 2001
Days to Decision 134 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
5d faster than avg
Panel avg: 139d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KLK Monitor, Oxygen, Cutaneous, 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.