LKD · Class II · 21 CFR 868.2480

FDA Product Code LKD: Monitor, Carbon-dioxide, Cutaneous

Leading manufacturers include Sentec AG, Radiometer Medical Aps and Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.

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
1–17 of 17
Cleared May 17, 2024
Sentec Digital Monitoring System (SDMS) tCOM+
K232516
Sentec AG
Anesthesiology · 273d
Cleared Dec 17, 2015
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
K151329
Sentec AG
Anesthesiology · 213d
Cleared Oct 22, 2013
PERIFLUX 6000
K131253
Perimed AB
Anesthesiology · 173d
Cleared Sep 30, 2011
PHILIPS INTELLIVUE TCG10
K110474
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Anesthesiology · 224d
Cleared Dec 03, 2010
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
K101690
Sentec AG
Anesthesiology · 170d
Cleared Feb 05, 2010
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
K093154
Radiometer Medical Aps
Anesthesiology · 122d
Cleared Mar 04, 2005
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
K043357
Linde Medical Sensors AG
Anesthesiology · 88d
Cleared Mar 01, 2005
TCM40 MONITORING SYSTEM
K043003
Radiometer Medical Aps
Anesthesiology · 120d
Cleared Aug 09, 2004
SENTEC DIGITAL MONITOR MODEL #SDM
K041548
Sentec, Inc.
Anesthesiology · 61d
Cleared Sep 23, 1999
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
K990960
Perimed, Inc.
Anesthesiology · 185d
Cleared Nov 05, 1998
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
K980756
Ge Medical Systems Information Technologies
Anesthesiology · 251d
Cleared May 03, 1994
TCPO2 9260 MODULE - SYSTEM ATHENA
K913013
S & W Medico Teknik
Anesthesiology · 1030d
Cleared Apr 16, 1990
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K900333
Radiometer America, Inc.
Anesthesiology · 83d
Cleared Apr 14, 1989
TRANSCUTANEOUS O2/CO2 MONITOR
K890517
Novametrix Medical Systems, Inc.
Anesthesiology · 74d
Cleared Dec 16, 1988
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
K883606
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.