# K022203: Abbott Lifecare Pca 3 Infuser, Model 12384

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Aug 1, 2002 after 27 days
- Product code: MEA (Pump, Infusion, Pca)
- 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.
6 later devices descend from it; 3 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott Lifecare 4100 PCA Infuser Plus II: named in the summary without a submission number

## Most influential descendants
- K042800: Lifecare Pca Infusion System with Hospira Mednet Software (2004), 3 descendants of its own
- K120209: Patient Controlled Analgesia (Pca) Button Cable (2012), 1 descendant of its own
- K043256: Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03 (2004), 1 descendant of its own
- K220695: Elite Biomedical Solutions Dose Request Cord (2022), 0 descendants of its own
- K143612: LifeCare PCA Infusion System (2016), 0 descendants of its own

## Recalls of this device
- Aug 11, 2009 · Not classified · Z-0017-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Nov 2, 2005 · Not classified · Z-0601-06: Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.

## Indications for use
The Abbott LifeCareB PCA 3 Infuser is indicated for volumetric infusion of analgesic drugs by continuous or patient demanded (PCA) intravenous administration. The Abbott Lifecare@ PCA 3 Infuser is also indicated for short-term continuous (less than 96 hours) epidural administration of analgesic drugs.

Source page: https://510kreport.com/device/K022203
Methodology: https://510kreport.com/methodology