Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terumo Cardiovascular Systems Corporation — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
292 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024-04-25 | 125 | 2 |
| K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2023-04-18 | 292 | 0 |
| K200091 | Capiox iCP Centrifugal Pump | Terumo Cardiovascular Systems Corporation | 2021-11-18 | 672 | 0 |
| K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018-11-02 | 88 | 0 |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientati | Terumo Cardiovascular Systems Corporation | 2018-06-22 | 72 | 1 |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientati | Terumo Cardiovascular Systems Corporation | 2018-03-29 | 262 | 0 |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-08-17 | 24 | 0 |
| K163531 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2017-06-07 | 173 | 0 |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion Syst | Terumo Cardiovascular Systems Corporation | 2016-11-17 | 37 | 0 |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | 2016-04-21 | 84 | 0 |
| K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-12-16 | 23 | 2 |
| K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell Res | Terumo Cardiovascular Systems Corporation | 2015-12-03 | 28 | 0 |
| K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-12-02 | 33 | 0 |
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arteri | Terumo Cardiovascular Systems Corporation | 2015-11-19 | 141 | 1 |
| K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arteri | Terumo Cardiovascular Systems Corporation | 2015-10-20 | 147 | 0 |
| K151349 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2015-08-27 | 99 | 0 |
| K150536 | Terumo Circuit Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-05 | 63 | 0 |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-01 | 59 | 0 |
| K142500 | One Way Soft Valve | Terumo Cardiovascular Systems Corporation | 2015-01-29 | 146 | 0 |
| K140008 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | Terumo Cardiovascular Systems Corporation | 2014-10-31 | 302 | 0 |
| K140774 | TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOI | Terumo Cardiovascular Systems Corporation | 2014-06-02 | 66 | 0 |
| K132811 | SARNS SOFT-FLOW EXTENDED AORTIC CANNULA | Terumo Cardiovascular Systems Corporation | 2014-02-27 | 171 | 0 |
| K131618 | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corporation | 2013-09-27 | 116 | 0 |
| K121209 | TERUMO PALL AL20X ARTERIAL FILTER | Terumo Cardiovascular Systems Corporation | 2012-05-08 | 18 | 0 |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | 2010-05-19 | 146 | 0 |
| K041697 | TERUMO CIRCUIT CONNECTORS | Terumo Cardiovascular Systems Corporation | 2004-08-11 | 50 | 0 |
| K033800 | CAPIOX CARDIOTOMY RESERVOIR | Terumo Cardiovascular Systems Corporation | 2004-02-10 | 67 | 0 |
| K022918 | ADAPTERS WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-11-27 | 84 | 0 |
| K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-09-19 | 22 | 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