Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2500](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2500) → KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia # KLK · Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia _Anesthesiology · 21 CFR 868.2500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK ## Overview - **Product Code:** KLK - **Device Name:** Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia - **Regulation:** [21 CFR 868.2500](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2500) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document. ## Recent Cleared Devices (20 of 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K003943](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K003943.md) | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | May 4, 2001 | SESE | | [K991644](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K991644.md) | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | May 21, 1999 | SESE | | [K980287](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K980287.md) | SIEMENS SC9000/SC9015 TCP02/C02 MODULE | Siemens Medical Solutions USA, Inc. | Aug 12, 1998 | SESE | | [K924709](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K924709.md) | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Air-Shields, Inc. | Jan 17, 1996 | SESE | | [K924679](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K924679.md) | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | Air-Shields Vickers, Inc. | Feb 21, 1995 | SESE | | [K925910](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K925910.md) | HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE | Hewlett-Packard Co. | Jul 29, 1993 | SESE | | [K893133](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K893133.md) | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX | Mennen Medical, Inc. | Jul 14, 1989 | SESE | | [K870805](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K870805.md) | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | Novametrix Medical Systems, Inc. | May 27, 1987 | SESE | | [K861861](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K861861.md) | 515A NEO-TRAK NEONATAL MONITOR | Ge Medical Systems Information Technologies | Jul 10, 1986 | SESE | | [K860124](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K860124.md) | HORIZON 2000 TRANSCUTANEOUS GAS MONITORING | Mennen Medical, Inc. | May 9, 1986 | SESE | | [K860951](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K860951.md) | KONTRON CUTANEOUS PO2 MONITOR 820 | Kontron Instruments, Inc. | Apr 9, 1986 | SESE | | [K852959](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K852959.md) | PO-510 TCPO2 MONITOR | Sumitomo Electric Industries, Inc. | Nov 29, 1985 | SESE | | [K851451](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K851451.md) | STAT GAS MODULE | Vulcan Laboratories, Inc. | Aug 2, 1985 | SESE | | [K844253](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K844253.md) | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 | Novametrix Medical Systems, Inc. | Jan 10, 1985 | SESE | | [K844079](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K844079.md) | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | Nov 30, 1984 | SESE | | [K842497](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K842497.md) | SERVOMED OXYMONITO SMK 363 | Litton Datamedix | Oct 4, 1984 | SESE | | [K842374](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K842374.md) | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | Sep 17, 1984 | SESE | | [K840993](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840993.md) | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 | Novametrix Medical Systems, Inc. | Apr 24, 1984 | SESE | | [K840919](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840919.md) | DAYPAK SYS VII CATHETER CARE KIT | Creative Care Systems, Inc. | Apr 17, 1984 | SESE | | [K840918](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840918.md) | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT | Biochem International, Inc. | Apr 17, 1984 | SESE | ## Top Applicants - Novametrix Medical Systems, Inc. — 13 clearances - Biochem International, Inc. — 3 clearances - Critikon Company, LLC — 2 clearances - Ge Medical Systems Information Technologies — 2 clearances - Hewlett-Packard Co. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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