Cleared Special

K991644 - MICROGAS 7650 TRANSCUTANEOUS MONITOR

K991644 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 8-day FDA review.

K991644 · Linde Medical Sensors AG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
8d
Days
Class 2
Risk

K991644 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 21, 1999 after a review of 8 days - a notably fast clearance 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K991644

510(k) Number K991644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1999
Decision Date May 21, 1999
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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 34
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K991644.
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
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
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805 · Novametrix Medical Systems, Inc. · May 1987
515A NEO-TRAK NEONATAL MONITOR
K861861 · Ge Medical Systems Information Technologies · Jul 1986