# K143612: LifeCare PCA Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Apr 8, 2016 after 476 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011442 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043256: Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03, Hospira, Inc. (2004) Summary page 4.
- K042800: Lifecare Pca Infusion System with Hospira Mednet Software, Hospira, Inc. (2004) Summary page 4.

## Indications for use
The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.

Source page: https://510kreport.com/device/K143612
Methodology: https://510kreport.com/methodology