# K880733: Bard Pca II Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 20, 1988 after 117 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 21, 2005 · Not classified · Z-0553-06: Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.
- Dec 15, 2005 · Not classified · Z-0636-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1428-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1429-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1431-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1430-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 20, 2004 · Not classified · Z-0443-05: The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.

Source page: https://510kreport.com/device/K880733
Methodology: https://510kreport.com/methodology