Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terumo Cardiovascular Systems Corp. — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
240 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo C | Terumo Cardiovascular Systems Corp. | 2015-12-02 | 33 | 0 |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2014-07-25 | 240 | 2 |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corp. | 2014-02-20 | 311 | 0 |
| K132451 | SARNS SOFT-FLOW AORTIC CANNULA | Terumo Cardiovascular Systems Corp. | 2014-02-18 | 196 | 0 |
| K133151 | SARNS HIGH FLOW AORTIC ARCH CANNULA | Terumo Cardiovascular Systems Corp. | 2014-02-03 | 109 | 0 |
| K130333 | CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESE | Terumo Cardiovascular Systems Corp. | 2013-03-13 | 30 | 0 |
| K130359 | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHEL | Terumo Cardiovascular Systems Corp. | 2013-03-13 | 28 | 0 |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2012-11-20 | 53 | 0 |
| K113214 | TLINK DATA MANAGEMENT SYSTEM (DMS) | Terumo Cardiovascular Systems Corp. | 2012-02-07 | 99 | 0 |
| K112587 | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLL | Terumo Cardiovascular Systems Corp. | 2011-12-19 | 104 | 0 |
| K092789 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | Terumo Cardiovascular Systems Corp. | 2010-05-12 | 244 | 2 |
| K092644 | TERUMO PRESSURE ISOLATOR | Terumo Cardiovascular Systems Corp. | 2009-12-10 | 105 | 0 |
| K083747 | TERUMO PALL AL3X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2009-08-20 | 246 | 0 |
| K083834 | TERUMO PALL AL6X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2009-04-17 | 115 | 0 |
| K090878 | MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN | Terumo Cardiovascular Systems Corp. | 2009-04-03 | 3 | 1 |
| K082321 | TERUMO ROCSAFE HYBRID PERFUSION SYSTEM | Terumo Cardiovascular Systems Corp. | 2009-02-13 | 184 | 0 |
| K083194 | VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM | Terumo Cardiovascular Systems Corp. | 2009-01-16 | 79 | 1 |
| K083301 | X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS | Terumo Cardiovascular Systems Corp. | 2008-12-18 | 38 | 37 |
| K080034 | THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 | Terumo Cardiovascular Systems Corp. | 2008-06-17 | 162 | 1 |
| K080774 | CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) | Terumo Cardiovascular Systems Corp. | 2008-04-17 | 29 | 0 |
| K071521 | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM | Terumo Cardiovascular Systems Corp. | 2007-11-21 | 170 | 5 |
| K070839 | MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR | Terumo Cardiovascular Systems Corp. | 2007-04-24 | 28 | 0 |
| K063618 | TENDERFLOW PERIATRIC ARTERIAL CANNULA | Terumo Cardiovascular Systems Corp. | 2007-03-13 | 98 | 24 |
| K062597 | TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA | Terumo Cardiovascular Systems Corp. | 2006-11-03 | 63 | 1 |
| K062381 | CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR | Terumo Cardiovascular Systems Corp. | 2006-08-24 | 9 | 2 |
| K051997 | CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL | Terumo Cardiovascular Systems Corp. | 2005-09-15 | 52 | 1 |
| K052205 | CAPIOX AF125X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | 2005-09-12 | 31 | 0 |
| K040023 | CAPIOX FLEXIBLE VENOUS RESERVOIR | Terumo Cardiovascular Systems Corp. | 2004-03-01 | 54 | 0 |
| K032128 | TERUMO AL8X ARTERIAL FILTER WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2003-08-01 | 22 | 0 |
| K031891 | VIRTUOSAPH | Terumo Cardiovascular Systems Corp. | 2003-07-29 | 46 | 0 |
| K030505 | CAPIOX CARDIOTOMY RESERVOIR | Terumo Cardiovascular Systems Corp. | 2003-05-14 | 84 | 0 |
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSIO | Terumo Cardiovascular Systems Corp. | 2003-03-20 | 196 | 150 |
| K023056 | CIRCUIT TUBINGS WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2002-11-26 | 74 | 0 |
| K020967 | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | Terumo Cardiovascular Systems Corp. | 2002-06-20 | 87 | 1 |
| K021020 | TERUMO GAS FILTER | Terumo Cardiovascular Systems Corp. | 2002-06-10 | 73 | 0 |
| K020998 | SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X | Terumo Cardiovascular Systems Corp. | 2002-04-04 | 7 | 2 |
| K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | 2002-01-22 | 85 | 0 |
| K010443 | CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL R | Terumo Cardiovascular Systems Corp. | 2001-12-11 | 300 | 0 |
| K013526 | CAPIOX RX HARDSHELL RESERVOIR | Terumo Cardiovascular Systems Corp. | 2001-11-15 | 23 | 0 |
| K012209 | CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X | Terumo Cardiovascular Systems Corp. | 2001-08-15 | 30 | 0 |
| K011804 | CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X | Terumo Cardiovascular Systems Corp. | 2001-07-09 | 28 | 0 |
| K003604 | ADAPTERS WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2001-02-07 | 78 | 0 |
| K002238 | CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2000-08-22 | 29 | 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