510(k) · Cleared
ClearedImpella Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Jul 8, 2010 as substantially equivalent to K063723 (Abiomed, Inc., 2008) after a 210-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Jul 8, 2010
- Review
- 210 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852698 (1985). 14 ancestors in all, the oldest K780953 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 3 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 2 generations backK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
- 1 generation backK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
- This deviceK093801 Impella ControllerAbiomed, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK110845 Impella Controller with Flow ControlAbiomed, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110845Impella Controller with Flow ControlAbiomed, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −3 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −2 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
| −1 | K063723 | Impella Recover LP 2.5 Percutaneous Cardiac Support System | Abiomed, Inc. | 2008 | — |
| 0 (this device) | K093801 | Impella Controller | Abiomed, Inc. | 2010 | — |
| +1 | K110845 | Impella Controller with Flow Control | Abiomed, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K063723 | Impella Recover LP 2.5 Percutaneous Cardiac Support SystemSummary page 1…Braun Vista Basic Purge System, which were cleared for use together as an extracorporeal bypass control unit for the RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM, K063723. 0. Device Description: The IMPELLA Controller is a microprocessor-based pump motor driver and purge system. It is designed to op… | 2008 |
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 |
|---|---|---|---|
| K110845 | Impella Controller with Flow Control | 2011 | 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K110845 (Abiomed, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063723.
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. 2010, 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 IMPELLA Controller is an extracorporeal bypass control unit intended to be used to provide
circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory
support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.
The Impella Controller is intended to be used by trained healthcare professionals in healthcare
facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments.
The IMPELLA Controller also displays pressure measurement readings, which are useful in
determining intravascular pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093801: Impella Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093801
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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