510(k) · Cleared
Recalled · Class II · 2025CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott (Formerly Thoratec Corporation) · QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Cleared on Dec 8, 2022 after a 150-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 8, 2022
- Review
- 150 days
- Class
- Class II
- Product code
- QNR
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK222038 CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory…Abbott (Formerly Thoratec Corporation) · 2022
- Descendant · cites it directly · 0 of its ownK234118 CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024
Most influential descendants
Showing 1 of 1 · See all- K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System | Abbott (Formerly Thoratec Corporation) | 2022 | — |
| +1 | K234118 | CentriMag™ Acute Circulatory Support System | Abbott Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
Planning a device in QNR? 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 K234118 CentriMag™ Acute Circulatory Support Systemscore 9.1 · 9 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 |
|---|---|---|---|
| * | — | FDA final order for Extracorporeal Circuit and Accessories for Long-Term… Named without a submission number | |
| † | K973011 | BPX80 Bio-Pump (BPX80) | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234118 | CentriMag™ Acute Circulatory Support System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2025 | Class II | Z-1099-2026 | Process design | Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K234118 (Abbott Medical, 2024) has gone furthest, with 0 descendants of its own.
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. 2022, 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™ Blood Pump for use with 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/K222038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222038: CentriMag™ Blood Pump for use with 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/K222038
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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