# K780953: Model 1861 Blood Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 31, 1978 after 83 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991783: AB-180 XC System, Model AB-180XC (2000), 13 descendants of its own
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), 7 descendants of its own
- K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 (2006), 4 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K110493: Tandemheart Pump (2011), 2 descendants of its own

Source page: https://510kreport.com/device/K780953
Methodology: https://510kreport.com/methodology