510(k) · Decided
DecidedImpella 2.5 Plus Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · PBL (no longer in FDA’s product-code list)
Cleared on Sep 6, 2012 as substantially equivalent to K063723 (Abiomed, Inc., 2008) after a 342-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Sep 6, 2012
- Review
- 342 days
- Product code
- PBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852698 (1985). 14 ancestors in all, the oldest K780953 (1978). No later device cites it as a predicate yet.
- 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 deviceK112892 Impella 2.5 Plus CatheterAbiomed, Inc. · 2012
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) | K112892 | Impella 2.5 Plus Catheter | Abiomed, Inc. | 2012 | — |
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 |
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 PBL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…ot currently exist for these devices. (i.e. none established under section 514 of the F D & C Act.) C. Predicate Device: The IMPELLA 2.5 (K063723) 0. Device Description: The Impella 2.5 Plus is an update to the design of the IMPELLA 2.5, which was cleared by the FDA in 2008… | 2008 |
| † | K110845 | Impella Controller with Flow Control | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 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.
- 2 other devices also cite its predicate K063723.
What is it indicated for?
The IMPELLA 2.5 PLUS Catheter 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 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112892: Impella 2.5 Plus Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112892
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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