Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maquet Cardiopulmonary, AG · Predicate Candidate Screening
44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
295 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxy | Maquet Cardiopulmonary, AG | 2015-05-07 | 92 | 1 |
| K140569 | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) | Maquet Cardiopulmonary, AG | 2014-11-19 | 258 | 0 |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VE | Maquet Cardiopulmonary, AG | 2014-07-07 | 38 | 2 |
| K133598 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2014-05-21 | 180 | 8 |
| K133265 | QUADROX-IR ADULT AND SMALL ADULT | Maquet Cardiopulmonary, AG | 2013-11-12 | 20 | 0 |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT | Maquet Cardiopulmonary, AG | 2013-10-30 | 110 | 0 |
| K132829 | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS | Maquet Cardiopulmonary, AG | 2013-10-08 | 29 | 1 |
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2013-07-05 | 28 | 0 |
| K130300 | HEATER-COOLER UNIT HCU 40 | Maquet Cardiopulmonary, AG | 2013-07-01 | 144 | 0 |
| K123288 | HEMOCONCENTRATOR | Maquet Cardiopulmonary, AG | 2013-06-26 | 247 | 0 |
| K130639 | ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CA | Maquet Cardiopulmonary, AG | 2013-05-16 | 66 | 0 |
| K112360 | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDRO | Maquet Cardiopulmonary, AG | 2011-09-15 | 29 | 5 |
| K102726 | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | 2011-04-04 | 195 | 8 |
| K102919 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VE | Maquet Cardiopulmonary, AG | 2011-03-11 | 161 | 2 |
| K103191 | QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INT | Maquet Cardiopulmonary, AG | 2011-03-08 | 131 | 4 |
| K102464 | QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTE | Maquet Cardiopulmonary, AG | 2011-03-04 | 189 | 4 |
| K102532 | HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLI | Maquet Cardiopulmonary, AG | 2011-02-25 | 175 | 0 |
| K101153 | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE | Maquet Cardiopulmonary, AG | 2010-12-08 | 229 | 3 |
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOL | Maquet Cardiopulmonary, AG | 2010-04-30 | 88 | 3 |
| K090690 | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-23 | 282 | 0 |
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, M | Maquet Cardiopulmonary, AG | 2009-12-23 | 296 | 1 |
| K090534 | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | Maquet Cardiopulmonary, AG | 2009-12-23 | 299 | 0 |
| K090518 | QUART ARTERIAL FILTER WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-18 | 295 | 0 |
| K090533 | HLM TUBING SET WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-18 | 294 | 0 |
| K090515 | ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF | Maquet Cardiopulmonary, AG | 2009-12-18 | 295 | 1 |
| K093522 | QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BI | Maquet Cardiopulmonary, AG | 2009-12-07 | 24 | 2 |
| K090689 | QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL | Maquet Cardiopulmonary, AG | 2009-10-29 | 227 | 4 |
| K090511 | QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE | Maquet Cardiopulmonary, AG | 2009-06-12 | 106 | 3 |
| K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 | Maquet Cardiopulmonary, AG | 2009-04-22 | 91 | 0 |
| K083794 | MECC SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2009-04-21 | 120 | 0 |
| K082117 | QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER | Maquet Cardiopulmonary, AG | 2009-02-18 | 205 | 4 |
| K082544 | QUART ARTERIAL FILTER WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-10-03 | 30 | 0 |
| K080470 | ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-R | Maquet Cardiopulmonary, AG | 2008-09-12 | 204 | 1 |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-09-11 | 192 | 186 |
| K072583 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, | Maquet Cardiopulmonary, AG | 2008-04-04 | 204 | 0 |
| K071774 | JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE | Maquet Cardiopulmonary, AG | 2008-01-23 | 208 | 0 |
| K070605 | JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE C | Maquet Cardiopulmonary, AG | 2008-01-04 | 305 | 0 |
| K072172 | JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE | Maquet Cardiopulmonary, AG | 2007-08-31 | 25 | 0 |
| K061628 | JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MOD | Maquet Cardiopulmonary, AG | 2006-08-22 | 71 | 0 |
| K061832 | JOSTRA HLM TUBING SETS WITH SAFELINE COATING | Maquet Cardiopulmonary, AG | 2006-08-11 | 43 | 0 |
| K061743 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MO | Maquet Cardiopulmonary, AG | 2006-07-21 | 30 | 0 |
| K061546 | QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 1 | Maquet Cardiopulmonary, AG | 2006-06-20 | 15 | 0 |
| K061072 | ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-R | Maquet Cardiopulmonary, AG | 2006-05-23 | 36 | 0 |
| K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | 2005-11-10 | 14 | 2 |
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