510(k) · Cleared
ClearedRotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on May 23, 2006 as substantially equivalent to K991864 (Jostra Medizintechnik AG, 2000) and 2 other predicates after a 36-day review. Its family tree reaches back 3 generations to 1993. 1 of the 15 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- May 23, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932252 (1993). 4 ancestors in all. 10 later devices descend from it, 4 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 2 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 1 generation backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- This deviceK061072 Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG · 2006
- Descendant · cites it directly · 3 of its ownK061743 Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2006
- Descendant · 2 generations on · 2 of its ownK090534 Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009
- Descendant · cites it directly · 2 of its ownK072583 Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2008
- Descendant · 3 generations on · 1 of its ownK102919 Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous…Maquet Cardiopulmonary, AG · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK090555 Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141432 Neonatal Venous Hardshell Cardiotomy Reservior…4 generations on · 2014
Most influential descendants
Showing 5 of 10 · See all- K061743Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum…Maquet Cardiopulmonary, AG · 2006 · cites it directly3descendants
- K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009 · 2 generations on2descendants
- K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG · 2008 · cites it directly2descendants
- K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG · 2011 · 3 generations on1descendant
- K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −2 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −1 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| 0 (this device) | K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 | Maquet Cardiopulmonary, AG | 2006 | — |
| +1 | K061743 | Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK… | Maquet Cardiopulmonary, AG | 2006 | — |
| +2 | K090534 | Venous Hardshell Cardiotomy Reserviors | Maquet Cardiopulmonary, AG | 2009 | — |
| +1 | K072583 | Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30… | Maquet Cardiopulmonary, AG | 2008 | — |
| +3 | K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2011 | 2 |
| +2 | K090555 | Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 | Maquet Cardiopulmonary, AG | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 1 |
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? (3)
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 |
|---|---|---|---|
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 4…l pump, coated Classification Names: Pump, blocd, non-roller-type, cardiopulmonary; (21 CFR 870.4360, product code: KFM) Predicate Devices: RotaFlow Centrifugal Pump (K991864) Quadrox Hollow Fiber Membrane Oxgenator Safeline (K992559, K030264) Device Description The Jostra RotaFlow Centrifugal Pump wit… | 2000 |
| * | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Summary page 4…er-type, cardiopulmonary; (21 CFR 870.4360, product code: KFM) Predicate Devices: RotaFlow Centrifugal Pump (K991864) Quadrox Hollow Fiber Membrane Oxgenator Safeline (K992559, K030264) Device Description The Jostra RotaFlow Centrifugal Pump with Safeline Coating is a sterile, non- pyrogenic device for… | 1999 |
| * | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Summary page 4…cardiopulmonary; (21 CFR 870.4360, product code: KFM) Predicate Devices: RotaFlow Centrifugal Pump (K991864) Quadrox Hollow Fiber Membrane Oxgenator Safeline (K992559, K030264) Device Description The Jostra RotaFlow Centrifugal Pump with Safeline Coating is a sterile, non- pyrogenic device for single us… | 2003 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061743 | Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum… | 2006 | 3 |
| K072583 | Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30 | 2008 | 2 |
| K070605 | Jostra Venous Softbag Reservoirs with and Without Safeline Coating | 2008 | 1 |
| K061832 | Jostra HLM Tubing Sets with Safeline Coating | 2006 | 0 |
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.
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K061743 (Maquet Cardiopulmonary, AG, 2006) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K991864.
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.
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 Rotaflow Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
* Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
* 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061072
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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