# K912928: Lifecare 4100 Pca Infuser Plus II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 26, 1991 after 82 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K982170: Fluidsense Fluid Delivery System (1998), 0 descendants of its own

## Recalls of this device
- Mar 8, 2013 · Class II · Z-2139-2016: Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut tha
- Aug 11, 2009 · Not classified · Z-0016-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Source page: https://510kreport.com/device/K912928
Methodology: https://510kreport.com/methodology