510(k) · Cleared
ClearedTandem Heart Escort (T.H.E.) Controller, Model 5140-8500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Aug 22, 2006 as substantially equivalent to K991783 (Cardiacassist, Inc., 2000) after a 97-day review. Its family tree reaches back 3 generations to 1985. 2 of the 11 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Aug 22, 2006
- Review
- 97 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K852698 (1985). 6 ancestors in all, the oldest K780953 (1978). 4 later devices descend from it, 2 citing it directly. 2 of the 11 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 deviceK061369 Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc. · 2006
- 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
- Descendant · cites it directly · 0 of its ownK073631 Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation · 2008
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · cites it directly2descendants
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on0descendants
- K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · 2 generations on0descendants
- K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation · 2008 · cites it directly0descendants
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) | K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 | Cardiacassist, Inc. | 2006 | — |
| +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 | — |
| +1 | K073631 | Orqis Extracorporeal Blood Pumping System, Model BPS-100 | Orqis Medical Corporation | 2008 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 DWA device
- #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 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 |
|---|---|---|---|
| * | K991783 | AB-180 XC System, Model AB-180XCSummary page 1…514 of the Food, Drug and Cosmetic Act. C. Predicate Device: CardiacAssist Model AB-1 80 XD Blood Pump Controller, K991783, found substantially equivalent November 1, 2000. Name changed to TandemHeart… | 2000 |
What descends from it? (4)
2 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 21 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 6 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 K991783.
How does its category compare?
All DWA devicesDWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for…
Read the full statement (131 words)
The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System.
In the U.S., the TandemHeart PTVA System 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 circulatory 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 aorta, liver transplant, etc.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061369
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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