510(k) · Cleared
ClearedIbc Flopump, Model 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corp. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Mar 24, 1999 as substantially equivalent to K852698 (Bio Medicus, Inc., 1985) after a 188-day review. Its family tree reaches back 1 generation to 1985. 3 later devices descend from it.
- Decided
- Mar 24, 1999
- Review
- 188 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852698 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- This deviceK983272 Ibc Flopump, Model 6000International Biophysics Corp. · 1999
- Descendant · cites it directly · 1 of its ownK170029 FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK250632 Arctx Cool Catheter SetArctx Medical · 2025
- Descendant · cites it directly · 0 of its ownK031300 Ibc Flopump with GBS CoatingGish Biomedical, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 2017 · cites it directly1descendant
- K250632Arctx Cool Catheter SetArctx Medical · 2025 · 2 generations on0descendants
- K031300Ibc Flopump with GBS CoatingGish Biomedical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| 0 (this device) | K983272 | Ibc Flopump, Model 6000 | International Biophysics Corp. | 1999 | — |
| +1 | K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | International Biophysics Corporation | 2017 | 1 |
| +2 | K250632 | Arctx Cool Catheter Set | Arctx Medical | 2025 | — |
| +1 | K031300 | Ibc Flopump with GBS Coating | Gish Biomedical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K852698 | Bio Medicus Bio Pump Model BP-80Summary page 1…NAME Non-roller type cardiopulmonary bypass blood pump (21 CFR - 870.4360) PREDICATE DEVICE OR LEGALLY MARKETED DEVICE Medtronic Bio-Medicus, Inc. — BP-80 Bio-Pump® (K852698) INTENDED USE The IBC FloPump centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console® to p… | 1985 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 IBC FloPump centrifugal blood pump is indicated for use and is compatible with all models of the Medtronic Bio-Medicus Bio-Consoles to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
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/K983272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983272: Ibc Flopump, Model 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983272
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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