DTQFDA Class 2 · 21 CFR 870.4220
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
52
Manufacturers
7
Flagged signals
17
Adverse-event reports
14,184
Code matrix
| FDA product code | DTQ |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4220 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2013 | 4 | 177.3 | 537 |
| Other | 2014 | 3 | 133.0 | 272 |
| Death | 2014 | 3 | 113.5 | 234 |
| Other | 2014 | 211 | 84.9 | 17,326 |
| Other | 2013 | 169 | 67.9 | 11,035 |
| Other | 2012 | 161 | 64.7 | 9,997 |
| Other | 2015 | 77 | 30.9 | 2,193 |
| Other | 2011 | 63 | 25.2 | 1,442 |
| Other | 2011 | 30 | 12.0 | 292 |
| Other | 2013 | 26 | 10.4 | 212 |
| Other | 2010 | 20 | 8.0 | 116 |
| Other | 2010 | 20 | 8.0 | 116 |
| Other | 2012 | 20 | 8.0 | 116 |
| Other | 2014 | 13 | 5.2 | 40 |
| Other | 2010 | 13 | 5.2 | 40 |
| Other | 2009 | 9 | 3.6 | 14 |
| Death | 2022 | 28 | 2.6 | 26 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 14,184 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | 5 | 2023 | — |
| 3M Health Care, Sarns | 5 | 1992 | — |
| Shiley, Inc. | 3 | 1986 | — |
| Cobe Laboratories, Inc. | 3 | 1987 | — |
| Maquet Cardiopulmonary, AG | 2 | 2014 | — |
| Terumo Cardiovascular Systems Corp. | 2 | 2014 | — |
| Gambro, Inc. | 1 | 1982 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Essenz HLM, Essenz ILBM · Livanova Deutschland, GmbH510(k) · 2023-08-24
Terumo Advanced Perfusion System 1 · Terumo Cardiovascular Systems Corporation510(k) · 2023-04-18
Essenz HLM · Livanova Deutschland, GmbH510(k) · 2023-03-09
Stockert S5 System · Livanova Deutschland, GmbH510(k) · 2021-04-05
Century Perfusion System · Century Hlm, LLC510(k) · 2021-03-07
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) · Spectrum Medical , Ltd.510(k) · 2019-05-24
Quantum Pump Console · Spectrum Medical , Ltd.510(k) · 2018-05-25
Advanced Perfusion System 1 · Terumo Cardiovascular Systems Corporation510(k) · 2017-08-17
Advanced Perfusion System 1 · Terumo Cardiovascular Systems Corporation510(k) · 2017-06-07
Advanced Perfusion System 1 · Terumo Cardiovascular Systems Corporation510(k) · 2015-12-16
Advanced Perfusion System 1 · Terumo Cardiovascular Systems Corporation510(k) · 2015-08-27
CARDIOHELP SYSTEM · Maquet Cardiopulmonary, AG510(k) · 2014-05-21
ADVANCED PERFUSION SYSTEM 1 · Terumo Cardiovascular Systems Corp.510(k) · 2014-02-20
CARDIOHELP SYSTEM · Maquet Cardiopulmonary, AG510(k) · 2011-04-04
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE · Sorin Group Deutschland GmbH510(k) · 2011-01-20
SORIN C5 SYSTEM MODEL 58-00-00 · Sorin Group Deutschland GmbH510(k) · 2010-01-15
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM · Sorin Group Deutschland GmbH510(k) · 2009-11-05
LIFEBRIDGE B2T, MODEL 7001 · Lifebridge Medizintechnik AG510(k) · 2009-10-15
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 · Sorin Group Deutschland GmbH510(k) · 2009-07-02
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER · Sorin Group Deutschland GmbH510(k) · 2008-07-30
MODIFICATION TO: STOCKERT S5 SYSTEM · Sorin Group Deutschland GmbH510(k) · 2007-07-06
PERFORMER CBP SYSTEM · Rand S.R.L.510(k) · 2007-03-21
MODIFICATION TO STOCKERT S5 SYSTEM · Sorin Group Deutschland GmbH510(k) · 2006-09-28
STOCKERT S5 SYSTEM · Sorin Group Deutschland GmbH510(k) · 2006-06-02
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB · Rand S.R.L.510(k) · 2006-03-15
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.