510(k) · Cleared
Recalled · 2010Impella 5.0 Catheter Family
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 Apr 16, 2009 as substantially equivalent to K063723 (Abiomed, Inc., 2008) and 5 other predicates after a 177-day review. Its family tree reaches back 4 generations to 1985. 2 of the 29 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 16, 2009
- Review
- 177 days
- Class
- Class II
- Product code
- KFM
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 4 generations to K845045 (1985). 25 ancestors in all, the oldest K780953 (1978). 3 later devices descend from it, 1 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985 · Recalled
- 3 generations backK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
- 2 generations backK052081 Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · Recalled
- 1 generation backK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
- This deviceK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K845045 | Venous Return Catheter SS-1 | Dlp, Inc. | 1985 | 3 |
| −3 | K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | Medtronic Perfusion Systems | 2003 | — |
| −2 | K052081 | Remote Access Perfusion (Rap) Femoral Venous Cannula | Estech, Inc. | 2005 | 1 |
| −1 | K060101 | Estech Aortic Easy Flow Cannula | Endoscopic Technologies, Inc. | 2006 | — |
| 0 (this device) | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | — |
| +1 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +2 | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | Class I |
| +2 | K133265 | Quadrox-IR Adult and Small Adult | Maquet Cardiopulmonary, AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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? (6)
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…xtracorporeal Circulatory Support System Classification Name: Non-roller Type Cardiopulmonary Bypass (CPB) Blood Pump Predicate Devices: IMPELLA 2.5 (K063723) Estech 21 Fr RAP Cannula (K032632) Estech 21 Fr RAP Femoral Cannula (K… | 2008 |
| * | K032632 | Remote Access Perfusion Cannula Left Axillary 21 FrenchSummary page 1…Non-roller Type Cardiopulmonary Bypass (CPB) Blood Pump Predicate Devices: IMPELLA 2.5 (K063723) Estech 21 Fr RAP Cannula (K032632) Estech 21 Fr RAP Femoral Cannula (K990573) Estech Easy Flow Aortic Can… | 2003 |
| * | K990573 | Estech Arterial Remote Access Perfusion CannulaSummary page 1…te Devices: IMPELLA 2.5 (K063723) Estech 21 Fr RAP Cannula (K032632) Estech 21 Fr RAP Femoral Cannula (K990573) Estech Easy Flow Aortic Cannulae (K060101) Calmed 18-24 Fr Aortic Arch… | 1999 |
| * | K060101 | Estech Aortic Easy Flow CannulaSummary page 1…Estech 21 Fr RAP Cannula (K032632) Estech 21 Fr RAP Femoral Cannula (K990573) Estech Easy Flow Aortic Cannulae (K060101) Calmed 18-24 Fr Aortic Arch Cannulae (K943934) Sam's Delpin Centrifuga… | 2006 |
| * | K943934 | Aortic Arch CannulasSummary page 1…RAP Femoral Cannula (K990573) Estech Easy Flow Aortic Cannulae (K060101) Calmed 18-24 Fr Aortic Arch Cannulae (K943934) Sam's Delpin Centrifugal Pump (K913176) Device Description: The IMPELLA 5.0 catheter fami… | 1995 |
| * | K913176 | Delphin II Centrifugal SystemSummary page 1…sy Flow Aortic Cannulae (K060101) Calmed 18-24 Fr Aortic Arch Cannulae (K943934) Sam's Delpin Centrifugal Pump (K913176) Device Description: The IMPELLA 5.0 catheter family (IMPELLA 5.0) is an extension of the… | 1991 |
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 |
|---|---|---|---|
| K102726 | Cardiohelp System Class I | 2011 | 2 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2010 | Not classified | Z-2382-2010 | Process control | Pump may separate at the motor housing while device is explanted |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 25 ancestors have a recall of any class.
- Of its descendants, K102726 (Maquet Cardiopulmonary, AG, 2011) has gone furthest, with 2 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. 2009, 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 5.0 Catheters are intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to
provide circulatory support (for periods up to 6 hours) during procedures not requiring
cardiopulmonary bypass.
The IMPELLA 5.0 Catheters also provide pressure measurements which are useful in
determining intravascular pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083111: Impella 5.0 Catheter Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083111
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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