FDA Product Code LKD: Monitor, Carbon-dioxide, Cutaneous
Leading manufacturers include Sentec AG, Hewlett-Packard Co. and Ge Medical Systems Information Technologies.
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
Nov 05, 1998
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
Ge Medical Systems Information Technologies
Anesthesiology
251d
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.