510(k) · Cleared
ClearedCentriMag™ Acute Circulatory Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Cleared on Jan 26, 2024 as substantially equivalent to K200306 (Abbott (Formerly Thoratec Corporation), 2020) and 1 other predicate after a 29-day review. Its family tree reaches back 9 generations to 1985. 1 of the 23 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 26, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- QNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K852698 (1985). 22 ancestors in all. No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 5 generations between
- 3 generations backK102129 Levitronix 2ND Generation Centrimag Primary Console, Levitronix…Levitronix, LLC · 2010
- 2 generations backK191557 CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) · 2019
- 1 generation backK200306 CentriMag Circulatory Support System, CentriMag Return (Arterial)…Abbott (Formerly Thoratec Corporation) · 2020
- This deviceK234118 CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024
Show all 9 generations
- Root · 9 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 8 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 7 generations backK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- 6 generations backK053630 Levitronix Centrimag Primary ConsoleLevitronix, LLC · 2006
- 5 generations backK081221 Levitronix Centrimag Primary Console, Thoratec Centrimag Primary…Levitronix, LLC · 2008
- 4 generations backK083340 Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary…Levitronix, LLC · 2008 · Recalled
- 3 generations backK102129 Levitronix 2ND Generation Centrimag Primary Console, Levitronix…Levitronix, LLC · 2010
- 2 generations backK191557 CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) · 2019
- 1 generation backK200306 CentriMag Circulatory Support System, CentriMag Return (Arterial)…Abbott (Formerly Thoratec Corporation) · 2020
- This deviceK234118 CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024
Class I recalls in this family
- K020271 Levitronix Centrimag Extracorporeal Blood…3 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −8 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −7 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| −6 | K053630 | Levitronix Centrimag Primary Console | Levitronix, LLC | 2006 | — |
| −5 | K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console | Levitronix, LLC | 2008 | — |
| −4 | K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console | Levitronix, LLC | 2008 | 1 |
| −3 | K102129 | Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor | Levitronix, LLC | 2010 | — |
| −2 | K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | 2019 | — |
| −1 | K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit… | Abbott (Formerly Thoratec Corporation) | 2020 | — |
| 0 (this device) | K234118 | CentriMag™ Acute Circulatory Support System | Abbott Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2022 | 1 | 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.
1 device in this family has 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 QNR device
- #1 K250199 VitalFlow Consolescore 7.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Summary page 5…al 510(k) Submission 10. PREDICATE DEVICE NAME CentriMag™ Acute Circulatory Support System (K200306) CentriMag™ Blood Pump for use with… | 2020 |
| * | K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemSummary page 5…Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038) Note: The CentriMag Drainage (Venous) and Return… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QNR devicesQNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNR
Too few QNR 510(k)s in any year since 2007 to give a median.
Recalls per year · QNR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QNR
187in 2025
MAUDE reports naming product code QNR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 135 |
| 2025 | 1 | — | 1 | 187 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or ii. Temporary circulatory bypass for diversion of…
Read the full statement (168 words)
The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or
ii. Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava
The CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234118: CentriMag™ Acute Circulatory Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234118
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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