510(k) · Cleared
ClearedQuantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical S.R.L. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Aug 4, 2025 as substantially equivalent to K220842 (Qura S.R.L, 2023) after a 56-day review. Its family tree reaches back 5 generations to 1985. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 4, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K852698 (1985). 9 ancestors in all, the oldest K852807 (1985). No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 4 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 3 generations backK020271 Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Recalled (Class I)
- 2 generations backK090051 Levitronix Pedimag Blood Pump, Model 201-90052Levitronix, LLC · 2009 · Recalled
- 1 generation backK220842 Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated…Qura S.R.L · 2023
- This deviceK251762 Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated…Spectrum Medical S.R.L. · 2025
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 |
|---|---|---|---|---|---|
| −5 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −4 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −3 | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 | Levitronix, LLC | 2003 | Class I |
| −2 | K090051 | Levitronix Pedimag Blood Pump, Model 201-90052 | Levitronix, LLC | 2009 | 1 |
| −1 | K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum… | Qura S.R.L | 2023 | — |
| 0 (this device) | K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors… | Spectrum Medical S.R.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 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 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 |
|---|---|---|---|
| * | K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…Summary page 5…(OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K220842 IV. DEVICE DESCRIPTION The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-N… | 2023 |
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 40 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 5 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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 CP20NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods up to 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…
Read the full statement (108 words)
The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods up to 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.
Device is intended for adolescent (i.e., patients greater than 12 through 21 years of age).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251762: Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251762
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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