510(k) · Cleared
Recalled · Class II · 2019FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corporation · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Dec 15, 2017 as substantially equivalent to K991864 (Jostra Medizintechnik AG, 2000) and 1 other predicate after a 345-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 15, 2017
- Review
- 345 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K852698 (1985). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 1 generation backK983272 Ibc Flopump, Model 6000International Biophysics Corp. · 1999
- This deviceK170029 FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 2017
- Descendant · cites it directly · 0 of its ownK250632 Arctx Cool Catheter SetArctx Medical · 2025
Most influential descendants
Showing 1 of 1 · See all- K250632Arctx Cool Catheter SetArctx Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −1 | K983272 | Ibc Flopump, Model 6000 | International Biophysics Corp. | 1999 | — |
| 0 (this device) | K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | International Biophysics Corporation | 2017 | — |
| +1 | K250632 | Arctx Cool Catheter Set | Arctx Medical | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 5…circulatory pathway necessary for open surgical procedures on the aorta or vena cava. Predicate Devices: Maquet (Jostra) RotaFlow Centrifugal Pump – K991864 IBC FloPump Centrifugal Pump – K983272 Comparable Features to Predicate Device(s): This device is comparab… | 2000 |
| * | K983272 | Ibc Flopump, Model 6000Summary page 5…on the aorta or vena cava. Predicate Devices: Maquet (Jostra) RotaFlow Centrifugal Pump – K991864 IBC FloPump Centrifugal Pump – K983272 Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, design… | 1999 |
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 |
|---|---|---|---|
| K250632 | Arctx Cool Catheter Set | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2019 | Class II | Z-0318-2021 | Nonconforming Material/Component | The firm has become aware that they have distributed product that was expired. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K250632 (Arctx Medical, 2025) has gone furthest, with 0 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. 2017, 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 FloPump 32mL 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:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
i) 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/K170029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170029: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170029
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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