Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LKD — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
170 daysmedian FDA review time
273 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024-05-17 | 273 | 0 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Stays | Sentec AG | 2015-12-17 | 213 | 3 |
| K131253 | PERIFLUX 6000 | Perimed AB | 2013-10-22 | 173 | 0 |
| K110474 | PHILIPS INTELLIVUE TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-09-30 | 224 | 1 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WI | Sentec AG | 2010-12-03 | 170 | 6 |
| K093154 | TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM | Radiometer Medical Aps | 2010-02-05 | 122 | 1 |
| K043357 | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL | Linde Medical Sensors AG | 2005-03-04 | 88 | 0 |
| K043003 | TCM40 MONITORING SYSTEM | Radiometer Medical Aps | 2005-03-01 | 120 | 2 |
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM | Sentec, Inc. | 2004-08-09 | 61 | 3 |
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Perimed, Inc. | 1999-09-23 | 185 | 0 |
| K980756 | COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE | Ge Medical Systems Information Technologies | 1998-11-05 | 251 | 0 |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | S & W Medico Teknik | 1994-05-03 | 1030 | 0 |
| K905225 | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | Sechrist | 1991-04-10 | 141 | 0 |
| K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | Radiometer America, Inc. | 1990-04-16 | 83 | 0 |
| K891481 | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE | Siemens Medical Electronics | 1989-09-29 | 196 | 0 |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | Novametrix Medical Systems, Inc. | 1989-04-14 | 74 | 4 |
| K883606 | MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS | Hewlett-Packard Co. | 1988-12-16 | 115 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda