510(k) · Cleared
ClearedBio-Medicus Bio Console Models 540 a B C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Medicus, Inc. · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Jun 28, 1990 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 28, 1990
- Review
- 85 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK901584 Bio-Medicus Bio Console Models 540 a B CBio Medicus, Inc. · 1990
- Descendant · cites it directly · 2 of its ownK992592 A-Miniature Centrifugal Blood Pump System, Model CPB 2000A-Med Systems, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK020529 Large Centrifugal Blood Pump, Model CP-2A-Med Systems, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK013393 Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1HA-Med Systems, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See all- K992592A-Miniature Centrifugal Blood Pump System, Model CPB 2000A-Med Systems, Inc. · 2000 · cites it directly2descendants
- K020529Large Centrifugal Blood Pump, Model CP-2A-Med Systems, Inc. · 2002 · 2 generations on0descendants
- K013393Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1HA-Med Systems, Inc. · 2001 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901584 | Bio-Medicus Bio Console Models 540 a B C | Bio Medicus, Inc. | 1990 | — |
| +1 | K992592 | A-Miniature Centrifugal Blood Pump System, Model CPB 2000 | A-Med Systems, Inc. | 2000 | — |
| +2 | K020529 | Large Centrifugal Blood Pump, Model CP-2 | A-Med Systems, Inc. | 2002 | — |
| +2 | K013393 | Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1H | A-Med Systems, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWA? 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 DWA device
- #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992592 | A-Miniature Centrifugal Blood Pump System, Model CPB 2000 | 2000 | 2 |
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?
- Of its descendants, K992592 (A-Med Systems, Inc., 2000) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DWA devicesDWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K901584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K901584: Bio-Medicus Bio Console Models 540 a B C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K901584
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026