LKD · Monitor, Carbon-Dioxide, Cutaneous
Anesthesiology · 21 CFR 868.2480 · Class 2
Overview
| Product Code | LKD |
|---|---|
| Device Name | Monitor, Carbon-Dioxide, Cutaneous |
| Regulation | 21 CFR 868.2480 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | May 17, 2024 | SESE |
| K151329 | 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 | PERIFLUX 6000 | Perimed AB | Oct 22, 2013 | SESE |
| K110474 | PHILIPS INTELLIVUE TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | Sep 30, 2011 | SESE |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | Sentec AG | Dec 3, 2010 | SESE |
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | Radiometer Medical Aps | Feb 5, 2010 | SESE |
| K043357 | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 | Linde Medical Sensors AG | Mar 4, 2005 | SESE |
| K043003 | TCM40 MONITORING SYSTEM | Radiometer Medical Aps | Mar 1, 2005 | SESE |
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM | Sentec, Inc. | Aug 9, 2004 | SESE |
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Perimed, Inc. | Sep 23, 1999 | SESE |
| K980756 | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE | Ge Medical Systems Information Technologies | Nov 5, 1998 | SESE |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | S & W Medico Teknik | May 3, 1994 | SESE |
| K905225 | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | Sechrist | Apr 10, 1991 | SESE |
| K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | Radiometer America, Inc. | Apr 16, 1990 | SESE |
| K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | Siemens Medical Electronics | Sep 29, 1989 | SESE |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | Novametrix Medical Systems, Inc. | Apr 14, 1989 | SESE |
| K883606 | 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
