Cleared Special

K003943 - MICROGAS 7650 TRANSCUTANEOUS MONITOR

K003943 is an FDA 510(k) clearance for MICROGAS 7650 TRANSCUTANEOUS MONITOR, manufactured by Linde Medical Sensors AG. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Special 510(k) pathway after a 134-day FDA review.

K003943 · Linde Medical Sensors AG · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K003943

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

KLK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

All 36
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K003943.
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K991644 · Linde Medical Sensors AG · May 1999
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K980287 · Siemens Medical Solutions USA, Inc. · Aug 1998
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
K924709 · Air-Shields, Inc. · Jan 1996
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
K924679 · Air-Shields Vickers, Inc. · Feb 1995
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K925910 · Hewlett-Packard Co. · Jul 1993
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K893133 · Mennen Medical, Inc. · Jul 1989