510(k) · Cleared
Recalled · Class I · 2026Cardiohelp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on May 21, 2014 as substantially equivalent to K102726 (Maquet Cardiopulmonary, AG, 2011) after a 180-day review. Its family tree reaches back 10 generations to 1992. 3 of the 99 devices in its family, counting itself, have a Class I recall. It has been recalled 9 times, including a Class I recall.
- Decided
- May 21, 2014
- Review
- 180 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 9 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 10 generations to K922933 (1992). 98 ancestors in all, the oldest K771692 (1977). No later device cites it as a predicate yet. 3 of the 99 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 6 generations between
- 3 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- This deviceK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014
Show all 10 generations
- Root · 10 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 9 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 8 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 7 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 6 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 5 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 4 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 3 generations backK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK093522 Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- This deviceK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −9 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −8 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −7 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −6 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −5 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −4 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −3 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| −2 | K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and… | Maquet Cardiopulmonary, AG | 2009 | 3 |
| −1 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| 0 (this device) | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 1 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102726 | Cardiohelp SystemSummary page 1…: DTQ PREDICATE DEVCE INFORMATION: The modified CARDIOHELP System is substantially equivalent in function and intended use to the CAR-DIOHELP System (K 102726). DEVICE DESCRIPTION AND INTENDED USE: The CARDIOHELP System is a compact perfusion system consisting of the following compone… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2026 | Class II | Z-1300-2026 | Under Investigation by firm | Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or… |
| Apr 15, 2024 | Class II | Z-1831-2024 | Under Investigation by firm | The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. |
| Dec 28, 2023 | Class II | Z-1053-2024 | Labeling mix-ups | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device. |
| Nov 14, 2023 | Class III | Z-0595-2024 | Process design | CARDIOHELP-i System was not properly tested to measure leakage current |
| Nov 13, 2023 | Class II | Z-0605-2024 | Component design/selection | Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to… |
| Nov 6, 2023 | Class II | Z-0555-2024 | Labeling design | Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized… |
| Oct 12, 2023 | Class II | Z-0290-2024 | Device Design | It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. |
| Oct 10, 2023 | Class I | Z-0420-2024 | Under Investigation by firm | Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia. |
| Feb 18, 2022 | Class II | Z-0897-2022 | Process control | Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly… |
The 5 latest of 9 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 38 of the 98 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K102726.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration…
Read the full statement (124 words)
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is Intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.
The CARDIOI-ELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133598: Cardiohelp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133598
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026