Product code LKD— Anesthesiology
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
- Classification name
- Monitor, Carbon-Dioxide, Cutaneous
- Device class
- Class 2
- Regulation
- 21 CFR 868.2480
- Advisory panel
- Anesthesiology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code LKD
FDA has cleared devices under product code LKD between 1988 and 2024, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2015
- 2013
- 2011
- 2010
- 2005
- 2004
- 1999
- 1998
- 1994
- 1991
- 1990
- 1989
- 1988
Top applicants under product code LKD
Recent clearances under product code LKD
- K232516 — Sentec Digital Monitoring System (SDMS) tCOM+
- K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- K131253 — PERIFLUX 6000
- K110474 — PHILIPS INTELLIVUE TCG10
- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
- K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
- K043357 — TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
- K043003 — TCM40 MONITORING SYSTEM
- K041548 — SENTEC DIGITAL MONITOR MODEL #SDM
- K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
- K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
- K913013 — TCPO2 9260 MODULE - SYSTEM ATHENA
- K905225 — HBO CABLE ASSEMBLY, RADIOMETER TC-02
- K900333 — E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
- K891481 — SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
- K890517 — TRANSCUTANEOUS O2/CO2 MONITOR
- K883606 — MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
Data sourced from openFDA. This site is unofficial and independent of the FDA.