FDA Product Code LKD: Monitor, Carbon-dioxide, Cutaneous
Leading manufacturers include Radiometer Medical Aps, Hewlett-Packard Co. and Novametrix Medical Systems, Inc..
17
Total
17
Cleared
207d
Avg days
1988
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Monitor, Carbon-dioxide, Cutaneous Devices (Product Code LKD)
17 devices
Cleared
May 17, 2024
Sentec Digital Monitoring System (SDMS) tCOM+
Sentec AG
Anesthesiology
273d
Cleared
Sep 30, 2011
PHILIPS INTELLIVUE TCG10
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Anesthesiology
224d
Cleared
Feb 05, 2010
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
Radiometer Medical Aps
Anesthesiology
122d
Cleared
Mar 01, 2005
TCM40 MONITORING SYSTEM
Radiometer Medical Aps
Anesthesiology
120d
Cleared
Nov 05, 1998
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
Ge Medical Systems Information Technologies
Anesthesiology
251d
Cleared
May 03, 1994
TCPO2 9260 MODULE - SYSTEM ATHENA
S & W Medico Teknik
Anesthesiology
1030d
Cleared
Apr 16, 1990
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
Radiometer America, Inc.
Anesthesiology
83d
Cleared
Apr 14, 1989
TRANSCUTANEOUS O2/CO2 MONITOR
Novametrix Medical Systems, Inc.
Anesthesiology
74d
Cleared
Dec 16, 1988
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
Hewlett-Packard Co.
Anesthesiology
115d
About Product Code LKD - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code LKD since 1988, with 17 receiving FDA clearance (average review time: 207 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.