510(k) · Cleared
ClearedA-Miniature Centrifugal Blood Pump System, Model CPB 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Med Systems, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on May 4, 2000 as substantially equivalent to K852807 (Bio Medicus, Inc., 1985) and 3 other predicates after a 276-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- May 4, 2000
- Review
- 276 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K852698 (1985). 7 ancestors in all, the oldest K852807 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 1 generation backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- This deviceK992592 A-Miniature Centrifugal Blood Pump System, Model CPB 2000A-Med Systems, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK020529 Large Centrifugal Blood Pump, Model CP-2A-Med Systems, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK013393 Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1HA-Med Systems, Inc. · 2001
Most influential descendants
Showing 2 of 2 · See allView 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 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| 0 (this device) | K992592 | A-Miniature Centrifugal Blood Pump System, Model CPB 2000 | A-Med Systems, Inc. | 2000 | — |
| +1 | K020529 | Large Centrifugal Blood Pump, Model CP-2 | A-Med Systems, Inc. | 2002 | — |
| +1 | K013393 | Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1H | A-Med Systems, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K852807 | Bio Medicus Bio Pump Model BP-50Summary page 4…evices: Claim of Substantial Equivalence of the A-Med Miniature Centrifugal Pump System is made to: Centrifugal Blood Pump Medtronic Bio-Medicus BP-50 Centrifugal Pump (K852807) Medtronic Bio-Medicus BPX-80 Bio-Pump (K973011) Blood Pump Speed Controller Medtronic Bio-Medicus Bio-Console Model 540 (K9015… | 1985 |
| * | K973011 | BPX80 Bio-Pump (BPX80)Summary page 4…A-Med Miniature Centrifugal Pump System is made to: Centrifugal Blood Pump Medtronic Bio-Medicus BP-50 Centrifugal Pump (K852807) Medtronic Bio-Medicus BPX-80 Bio-Pump (K973011) Blood Pump Speed Controller Medtronic Bio-Medicus Bio-Console Model 540 (K901584) Sarns 7800 Centrifugal Pump Control Module (… | 1998 |
| * | K901584 | Bio-Medicus Bio Console Models 540 a B CSummary page 4…c Bio-Medicus BP-50 Centrifugal Pump (K852807) Medtronic Bio-Medicus BPX-80 Bio-Pump (K973011) Blood Pump Speed Controller Medtronic Bio-Medicus Bio-Console Model 540 (K901584) Sarns 7800 Centrifugal Pump Control Module (K950739) Device Description: The A-MED Miniature Centrifugal Pump i… | 1990 |
| * | K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemSummary page 4…nic Bio-Medicus BPX-80 Bio-Pump (K973011) Blood Pump Speed Controller Medtronic Bio-Medicus Bio-Console Model 540 (K901584) Sarns 7800 Centrifugal Pump Control Module (K950739) Device Description: The A-MED Miniature Centrifugal Pump is a sterile, disposable, non-pulsatile, non-roller pu… | 1995 |
What descends from it? (2)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K020529 (A-Med Systems, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K852807.
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 A-Med Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc).
The A-Med Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
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/K992592 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992592: A-Miniature Centrifugal Blood Pump System, Model CPB 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992592
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