510(k) · Cleared
Recalled · Class II · 2025Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qura S.R.L · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Nov 3, 2021 as substantially equivalent to K202169 (Qura S.R.L, 2020) after a 534-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 2021
- Review
- 534 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922933 (1992). 10 ancestors in all, the oldest K852698 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 4 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 3 generations backK030462 Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 2003 · Recalled
- 2 generations backK192850 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow…Qura S.R.L · 2020
- 1 generation backK202169 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow…Qura S.R.L · 2020
- This deviceK201320 Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L · 2021
- Descendant · cites it directly · 0 of its ownK250326 Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated…Spectrum Medical S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK233091 Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated…Qura S.R.L · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −5 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −4 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −3 | K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700 | Cobe Cardiovascular, Inc. | 2003 | 1 |
| −2 | K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal… | Qura S.R.L | 2020 | — |
| −1 | K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal… | Qura S.R.L | 2020 | — |
| 0 (this device) | K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Qura S.R.L | 2021 | — |
| +1 | K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors… | Spectrum Medical S.R.L. | 2025 | — |
| +1 | K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors… | Qura S.R.L | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 KFM? 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 KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 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 |
|---|---|---|---|
| * | K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Cleared while this submission was under review Summary page 4…ogy 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K202169 Page 5-1… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2025 | Class II | Z-1327-2025 | Process control | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K250326 (Spectrum Medical S.R.L., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, 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 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive of Spectrum Medical is intended to pump the blood through an extracorporeal circuit and to monitor pressure 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201320: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201320
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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