510(k) · Cleared
ClearedAB-180 XC System, Model AB-180XC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Nov 1, 2000 as substantially equivalent to K973011 (Medtronic Bio-Medicus, Inc., 1998) and 2 other predicates after a 526-day review. Its family tree reaches back 2 generations to 1985. 3 of the 19 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Nov 1, 2000
- Review
- 526 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K852698 (1985). 5 ancestors in all, the oldest K780953 (1978). 13 later devices descend from it, 3 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 1 generation backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- This deviceK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK061369 Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
- Descendant · cites it directly · 2 of its ownK110493 Tandemheart PumpCardiacassist, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008 · cites it directly7descendants
- K061369Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc. · 2006 · cites it directly4descendants
- K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 2 generations on3descendants
- K110493Tandemheart PumpCardiacassist, Inc. · 2011 · cites it directly2descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −1 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +1 | K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 | Cardiacassist, Inc. | 2006 | — |
| +2 | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | 1 |
| +1 | K110493 | Tandemheart Pump | Cardiacassist, Inc. | 2011 | 8 |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2019 | 1 | 1 |
| 2023 | 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.
3 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? (3)
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 |
|---|---|---|---|
| * | K973011 | BPX80 Bio-Pump (BPX80)Summary page 2…000011 Cardiac Assist Technologies, Inc. 510(k) Summary AB-180 XC System K991783 Predicate Device or Legally Marketed Device Medtronic BP-80 Bio-Pump®, K973011, K852698 Hemadyne Minnimed™ Model 1861 Extracorporeal Bloed Pump, K780953 Device Description The AB-180 XC Blood Pump provides… | 1998 |
| * | K852698 | Bio Medicus Bio Pump Model BP-80Summary page 2…== Page 2 === Cardiac Assist Technologies, Inc. 510(k) Summary AB-180 XC System K991783 Predicate Device or Legally Marketed Device Medtronic BP-80 Bio-Pump®, K973011, K852698 Hemadyne Minnimed™ Model 1861 Extracorporeal Bloed Pump, K780953 Device Description The AB-180 XC Blood Pump provides extracorp… | 1985 |
| * | K780953 | Model 1861 Blood PumpSummary page 2…-180 XC System K991783 Predicate Device or Legally Marketed Device Medtronic BP-80 Bio-Pump®, K973011, K852698 Hemadyne Minnimed™ Model 1861 Extracorporeal Bloed Pump, K780953 Device Description The AB-180 XC Blood Pump provides extracorporeal circulatory system support with the unique ability to local… | 1978 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K063723 (Abiomed, Inc., 2008) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K973011.
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.
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 AB-180 XC System consists of the AB-180 XC Blood Pump, a singleuse, disposable device; the AB-180 XD Blood Pump Controller, a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System. The AB-180 XC Blood Pump is a single use, disposable centrifugal-blood pump designed to circulate blood through an…
Read the full statement (143 words)
The AB-180 XC System consists of the AB-180 XC Blood Pump, a singleuse, disposable device; the AB-180 XD Blood Pump Controller, a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System.
The AB-180 XC Blood Pump is a single use, disposable centrifugal-blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal-bypass-circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatery support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava.and/or.aotta, liver transplant, etc.)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991783: AB-180 XC System, Model AB-180XC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991783
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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