Product Code: KLK FDA class 2 21 CFR 868.2500

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Anesthesiology

The Cutaneous Oxygen Monitor for Infants Not Under Gas Anesthesia is a non-invasive monitoring device that measures transcutaneous oxygen partial pressure through the skin surface, used to continuously assess oxygenation status in neonatal and pediatric patients. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLK and it is regulated under 21 CFR 868.2500 in the Anesthesiology specialty.

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Basic Information

Product Code: KLK
Device Class: FDA class 2
Regulation Number: 868.2500
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K003943	MICROGAS 7650 TRANSCUTANEOUS MONITOR	May 04, 2001	Substantially Equivalent	Linde Medical Sensors AG
K991644	MICROGAS 7650 TRANSCUTANEOUS MONITOR	May 21, 1999	Substantially Equivalent	Linde Medical Sensors AG
K980287	SIEMENS SC9000/SC9015 TCP02/C02 MODULE	Aug 12, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K924709	SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE	Jan 17, 1996	Substantially Equivalent	Air-Shields, Inc.
K924679	OXYCARE(TM) OXYGEN CONTROLLER/MONITOR	Feb 21, 1995	Substantially Equivalent	Air-Shields Vickers, Inc.
K925910	HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE	Jul 29, 1993	Substantially Equivalent	Hewlett-Packard Co.
K893133	HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX	Jul 14, 1989	Substantially Equivalent	Mennen Medical, Inc.
K870805	MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR	May 27, 1987	Substantially Equivalent	Novametrix Medical Systems, Inc.
K861861	515A NEO-TRAK NEONATAL MONITOR	Jul 10, 1986	Substantially Equivalent	Ge Medical Systems Information Technologies
K860124	HORIZON 2000 TRANSCUTANEOUS GAS MONITORING	May 09, 1986	Substantially Equivalent	Mennen Medical, Inc.
K860951	KONTRON CUTANEOUS PO2 MONITOR 820	Apr 09, 1986	Substantially Equivalent	Kontron Instruments, Inc.
K852959	PO-510 TCPO2 MONITOR	Nov 29, 1985	Substantially Equivalent	Sumitomo Electric Industries, Inc.
K851451	STAT GAS MODULE	Aug 02, 1985	Substantially Equivalent	Vulcan Laboratories, Inc.
K844253	NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2	Jan 10, 1985	Substantially Equivalent	Novametrix Medical Systems, Inc.
K844079	NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN	Nov 30, 1984	Substantially Equivalent	Novametrix Medical Systems, Inc.
K842497	SERVOMED OXYMONITO SMK 363	Oct 04, 1984	Substantially Equivalent	Litton Datamedix
K842374	NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN	Sep 17, 1984	Substantially Equivalent	Novametrix Medical Systems, Inc.
K840993	TRANSCUTANEOUS 800-OXYGEN MONITORS/801	Apr 24, 1984	Substantially Equivalent	Novametrix Medical Systems, Inc.
K840919	DAYPAK SYS VII CATHETER CARE KIT	Apr 17, 1984	Substantially Equivalent	Creative Care Systems, Inc.
K840918	MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT	Apr 17, 1984	Substantially Equivalent	Biochem International, Inc.
K831319	PATIENT MONITOR #404	Mar 22, 1984	Substantially Equivalent	Analogic Corp.
K834057	IL 301 PORTABLE TRANSCUT. OXYGEN MONI	Feb 04, 1984	Substantially Equivalent	Instrumentation Laboratory CO
K832652	OXY MONITOR 5-RANGE DUAL-THERMISTOR	Dec 22, 1983	Substantially Equivalent	Litton Medical Electronics
K830197	TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS	Nov 29, 1983	Substantially Equivalent	Diamond Shamrock Corp.
K831744	TRANSCUTANEOUS OXYGEN MONITOR OPTION	Jul 19, 1983	Substantially Equivalent	Ge Medical Systems Information Technologies
K831460	AS 30/TCP MODULE	Jul 12, 1983	Substantially Equivalent	Narco Scientific
K822328	IL 301 TRANSCUTANEOUS OXYGEN MONITOR	Sep 07, 1982	Substantially Equivalent	Instrumentation Laboratory CO
K821936	CRITIKON OXYGEN MONITOR, MODEL 8030	Aug 16, 1982	Substantially Equivalent	Critikon Company, LLC
K813350	NOVAMETRIX MODEL 807 TRANSCUT. MONITOR	Feb 12, 1982	Substantially Equivalent	Novametrix Medical Systems, Inc.
K813347	CRITIKON TRANSCUTANEOUS GAS MONITORS	Jan 26, 1982	Substantially Equivalent	Critikon Company, LLC
K813352	NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN	Jan 07, 1982	Substantially Equivalent	Novametrix Medical Systems, Inc.
K813351	NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER	Dec 31, 1981	Substantially Equivalent	Novametrix Medical Systems, Inc.
K812167	MODEL 78850 OXYGEN MONITOR	Aug 31, 1981	Substantially Equivalent	Hewlett-Packard Co.
K811836	PO-200 BLOOD OXYGEN MONITOR	Jul 27, 1981	Substantially Equivalent	Sumitomo Electric Industries, Inc.
K810999	CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS	Jun 24, 1981	Substantially Equivalent	Cordis Corp.
K811470	LIFESPAN 100	Jun 12, 1981	Substantially Equivalent	Biochem International, Inc.
K802978	TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300	Feb 02, 1981	Substantially Equivalent	Brattle Instrument Corp.
K802846	TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.	Dec 17, 1980	Substantially Equivalent	The London Co.
K800988	NOVAMETRIX TCOMETTE #809 TRANS. MONITOR	May 28, 1980	Substantially Equivalent	Novametrix Medical Systems, Inc.
K800631	OXYMETER	Apr 02, 1980	Substantially Equivalent	Dragerwerk AG
K791559	ROCHE SENSOR ADAPTOR	Nov 21, 1979	Substantially Equivalent	Roche Medical Electronics, Inc.
K792011	TC02M PRECISION GAS CALIBRATOR	Nov 16, 1979	Substantially Equivalent	Novametrix Medical Systems, Inc.
K792010	TC02M ELECTRODE ADHESIVE RINGS	Oct 26, 1979	Substantially Equivalent	Novametrix Medical Systems, Inc.
K792009	TC02 M OXYGEN ELECTRODE CONTACT	Oct 26, 1979	Substantially Equivalent	Novametrix Medical Systems, Inc.
K791152	TCO2M MODEL 818	Aug 03, 1979	Substantially Equivalent	Novametrix Medical Systems, Inc.
K781910	MONITOR, SENSOMATIII OXYGEN	Dec 26, 1978	Substantially Equivalent	Biochem International, Inc.
K780458	TRANSCUTANEOUS OXYGEN PERFUSION MONITOR	Oct 10, 1978	Substantially Equivalent	Narco Air-Shields