510(k) · Cleared
ClearedHimex Centriflow Centrifugal Perfusion Pump System (CFK01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Himex Production Corp. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Feb 6, 1998 as substantially equivalent to K920077 (International Medical Products, Inc., 1993) after a 199-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Feb 6, 1998
- Review
- 199 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920077 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK920077 Nikkiso NK PumpInternational Medical Products, Inc. · 1993
- This deviceK972740 Himex Centriflow Centrifugal Perfusion Pump System (CFK01)Himex Production Corp. · 1998
- Descendant · cites it directly · 0 of its ownK020571 Stockert Centrifugal Pump ConsoleStockert Instrumente GmbH · 2002
Most influential descendants
Showing 1 of 1 · See all- K020571Stockert Centrifugal Pump ConsoleStockert Instrumente GmbH · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920077 | Nikkiso NK Pump | International Medical Products, Inc. | 1993 | — |
| 0 (this device) | K972740 | Himex Centriflow Centrifugal Perfusion Pump System (CFK01) | Himex Production Corp. | 1998 | — |
| +1 | K020571 | Stockert Centrifugal Pump Console | Stockert Instrumente GmbH | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K920077 | Nikkiso NK PumpSummary page 1…low ™ CLASSIFICATION NAME: Extracorporeal Centrifugal Blood Pump The HIMEX Centriflow ™ is a speed controlled motor device for operating a Nikkiso HMS-12 (FDA 510(k) # K920077) disposable centrifugal pump head. The motor turns a driver magnet at a speed that is set by the device operator. The Driver Magn… | 1993 |
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 |
|---|---|---|---|
| K020571 | Stockert Centrifugal Pump Console | 2002 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K020571 (Stockert Instrumente GmbH, 2002) 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.
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 HIMEX Centriflow System is indicated for use in the maintenance
of vital circulatory support as an extracorporeal circuit that
is intended for use in cardiopulmonary bypass procedures less
than six hours in duration.
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/K972740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972740: Himex Centriflow Centrifugal Perfusion Pump System (CFK01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972740
Report an extraction error
Are you the manufacturer?
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