510(k) · Cleared
ClearedImpella Recover LP 2.5 Percutaneous Cardiac Support System
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 May 30, 2008 as substantially equivalent to K991783 (Cardiacassist, Inc., 2000) and 4 other predicates after a 532-day review. Its family tree reaches back 3 generations to 1985. 2 of the 21 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- May 30, 2008
- Review
- 532 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K852698 (1985). 13 ancestors in all, the oldest K780953 (1978). 7 later devices descend from it, 3 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 2 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 1 generation backK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
- This deviceK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK093801 Impella ControllerAbiomed, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · cites it directly3descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
- K093801Impella ControllerAbiomed, Inc. · 2010 · cites it directly1descendant
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on0descendants
- K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −2 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −1 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
| 0 (this device) | K063723 | Impella Recover LP 2.5 Percutaneous Cardiac Support System | Abiomed, Inc. | 2008 | — |
| +1 | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | 1 |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +1 | K093801 | Impella Controller | Abiomed, Inc. | 2010 | — |
| +3 | K133598 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2014 | Class I |
| +3 | 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 |
| 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K991783 | AB-180 XC System, Model AB-180XCSummary page 4…870.1200) Product Code: 74KFM, 74DWF, 74DQO c. Legally Marketed Predicate Devices • TandemHeart PTVA System - K991783, K052570 ,K924642 , K924643 • Vascular Solutions Langston Dual Lumen Catheter - K050168 d. Device Description: The… | 2000 |
| * | K052570 | Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Summary page 4…870.1200) Product Code: 74KFM, 74DWF, 74DQO c. Legally Marketed Predicate Devices • TandemHeart PTVA System - K991783, K052570 ,K924642 , K924643 • Vascular Solutions Langston Dual Lumen Catheter - K050168 d. Device Description: The IMPELLA… | 2006 |
| * | K924642 | Medtronic Bio-Medicus Femoral Cannula/IntroducerSummary page 4…870.1200) Product Code: 74KFM, 74DWF, 74DQO c. Legally Marketed Predicate Devices • TandemHeart PTVA System - K991783, K052570 ,K924642 , K924643 • Vascular Solutions Langston Dual Lumen Catheter - K050168 d. Device Description: The IMPELLA RECOVER®… | 1993 |
| * | K924643 | Medtronic Bio-Medicus Cannula Insertion KitSummary page 4…70.1200) Product Code: 74KFM, 74DWF, 74DQO c. Legally Marketed Predicate Devices • TandemHeart PTVA System - K991783, K052570 ,K924642 , K924643 • Vascular Solutions Langston Dual Lumen Catheter - K050168 d. Device Description: The IMPELLA RECOVER® LP 2.5 Per… | 1992 |
| * | K050168 | Langston Dual Lumen Pressure Monitoring CatheterSummary page 4…Legally Marketed Predicate Devices • TandemHeart PTVA System - K991783, K052570 ,K924642 , K924643 • Vascular Solutions Langston Dual Lumen Catheter - K050168 d. Device Description: The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System (IMPELLA RECOVER LP 2.5 System)… | 2005 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 23 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K083111 (Abiomed, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K991783.
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. 2008, 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 RECOVER® LP 2.5 Percutaneous Cardiac Support System is intended for partial circulatory support using an extracorporeal bypass control unit. for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063723
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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