# K941984: Sabratek 6060 Homerun Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sabratek Corp.
- Decided: Jul 19, 1994 after 85 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980751: Sabratek 4040 Infusion Pump (1999), 0 descendants of its own
- K981816: Cue Ambulatory Volumetric Infusion Pump (1998), 0 descendants of its own
- K981776: Alexander Manufacturing CO. Battery Part Number MC146X (1998), 0 descendants of its own

## Recalls of this device
- Aug 17, 2005 · Not classified · Z-1592-05: Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher

Source page: https://510kreport.com/device/K941984
Methodology: https://510kreport.com/methodology