Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2480](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2480) → LKD — Monitor, Carbon-Dioxide, Cutaneous # LKD · Monitor, Carbon-Dioxide, Cutaneous _Anesthesiology · 21 CFR 868.2480 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD ## Overview - **Product Code:** LKD - **Device Name:** Monitor, Carbon-Dioxide, Cutaneous - **Regulation:** [21 CFR 868.2480](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2480) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement. ## Classification Rationale Class II (special controls). The special control for this device 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 special control for this device 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 (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K232516](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K232516.md) | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | May 17, 2024 | SESE | | [K151329](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K151329.md) | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | Sentec AG | Dec 17, 2015 | SESE | | [K131253](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K131253.md) | PERIFLUX 6000 | Perimed AB | Oct 22, 2013 | SESE | | [K110474](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K110474.md) | PHILIPS INTELLIVUE TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | Sep 30, 2011 | SESE | | [K101690](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K101690.md) | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | Sentec AG | Dec 3, 2010 | SESE | | [K093154](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K093154.md) | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | Radiometer Medical Aps | Feb 5, 2010 | SESE | | [K043357](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K043357.md) | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 | Linde Medical Sensors AG | Mar 4, 2005 | SESE | | [K043003](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K043003.md) | TCM40 MONITORING SYSTEM | Radiometer Medical Aps | Mar 1, 2005 | SESE | | [K041548](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K041548.md) | SENTEC DIGITAL MONITOR MODEL #SDM | Sentec, Inc. | Aug 9, 2004 | SESE | | [K990960](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K990960.md) | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Perimed, Inc. | Sep 23, 1999 | SESE | | [K980756](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K980756.md) | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE | Ge Medical Systems Information Technologies | Nov 5, 1998 | SESE | | [K913013](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K913013.md) | TCPO2 9260 MODULE - SYSTEM ATHENA | S & W Medico Teknik | May 3, 1994 | SESE | | [K905225](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K905225.md) | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | Sechrist | Apr 10, 1991 | SESE | | [K900333](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K900333.md) | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | Radiometer America, Inc. | Apr 16, 1990 | SESE | | [K891481](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K891481.md) | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | Siemens Medical Electronics | Sep 29, 1989 | SESE | | [K890517](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K890517.md) | TRANSCUTANEOUS O2/CO2 MONITOR | Novametrix Medical Systems, Inc. | Apr 14, 1989 | SESE | | [K883606](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD/K883606.md) | MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS | Hewlett-Packard Co. | Dec 16, 1988 | SESE | ## Top Applicants - Sentec AG — 3 clearances - Radiometer Medical Aps — 2 clearances - Siemens Medical Electronics — 1 clearance - Sentec, Inc. — 1 clearance - Sechrist — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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