KLK · Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Anesthesiology · 21 CFR 868.2500 · Class 2
Overview
| Product Code | KLK |
|---|---|
| Device Name | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Regulation | 21 CFR 868.2500 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | May 4, 2001 | SESE |
| K991644 | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | May 21, 1999 | SESE |
| K980287 | SIEMENS SC9000/SC9015 TCP02/C02 MODULE | Siemens Medical Solutions USA, Inc. | Aug 12, 1998 | SESE |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Air-Shields, Inc. | Jan 17, 1996 | SESE |
| K924679 | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | Air-Shields Vickers, Inc. | Feb 21, 1995 | SESE |
| K925910 | HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE | Hewlett-Packard Co. | Jul 29, 1993 | SESE |
| K893133 | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX | Mennen Medical, Inc. | Jul 14, 1989 | SESE |
| K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | Novametrix Medical Systems, Inc. | May 27, 1987 | SESE |
| K861861 | 515A NEO-TRAK NEONATAL MONITOR | Ge Medical Systems Information Technologies | Jul 10, 1986 | SESE |
| K860124 | HORIZON 2000 TRANSCUTANEOUS GAS MONITORING | Mennen Medical, Inc. | May 9, 1986 | SESE |
| K860951 | KONTRON CUTANEOUS PO2 MONITOR 820 | Kontron Instruments, Inc. | Apr 9, 1986 | SESE |
| K852959 | PO-510 TCPO2 MONITOR | Sumitomo Electric Industries, Inc. | Nov 29, 1985 | SESE |
| K851451 | STAT GAS MODULE | Vulcan Laboratories, Inc. | Aug 2, 1985 | SESE |
| K844253 | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 | Novametrix Medical Systems, Inc. | Jan 10, 1985 | SESE |
| K844079 | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | Nov 30, 1984 | SESE |
| K842497 | SERVOMED OXYMONITO SMK 363 | Litton Datamedix | Oct 4, 1984 | SESE |
| K842374 | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | Sep 17, 1984 | SESE |
| K840993 | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 | Novametrix Medical Systems, Inc. | Apr 24, 1984 | SESE |
| K840919 | DAYPAK SYS VII CATHETER CARE KIT | Creative Care Systems, Inc. | Apr 17, 1984 | SESE |
| K840918 | 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
