Atlas FDA

LKD

17 FDA 510(k) clearances · Product code

170 daysmedian time to decision
273 days90th percentile
17clearances measured

FDA profile

Official device name
Monitor, Carbon-Dioxide, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2480
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1993: 1 · 1996: 1 · 2010: 8 · 2014: 21 · 2015: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Sentec Digital Monitoring System (SDMS) tCOM+ (K232516)Sentec AG2024-05-17
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (K151329)Sentec AG2015-12-17
PERIFLUX 6000 (K131253)Perimed AB2013-10-22
PHILIPS INTELLIVUE TCG10 (K110474)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-09-30
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE (K101690)Sentec AG2010-12-03
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (K093154)Radiometer Medical Aps2010-02-05
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (K043357)Linde Medical Sensors AG2005-03-04
TCM40 MONITORING SYSTEM (K043003)Radiometer Medical Aps2005-03-01
SENTEC DIGITAL MONITOR MODEL #SDM (K041548)Sentec, Inc.2004-08-09
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (K990960)Perimed, Inc.1999-09-23
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (K980756)Ge Medical Systems Information Technologies1998-11-05
TCPO2 9260 MODULE - SYSTEM ATHENA (K913013)S & W Medico Teknik1994-05-03
HBO CABLE ASSEMBLY, RADIOMETER TC-02 (K905225)Sechrist1991-04-10
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. (K900333)Radiometer America, Inc.1990-04-16
SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE (K891481)Siemens Medical Electronics1989-09-29
TRANSCUTANEOUS O2/CO2 MONITOR (K890517)Novametrix Medical Systems, Inc.1989-04-14
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS (K883606)Hewlett-Packard Co.1988-12-16

Track LKD automatically

Every clearance here is in the API, with alerts when new ones post.