# K955180: Cadd-Pca, -Micro, -Prizm Ambulatory Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: May 23, 1996 after 192 days
- Product code: FRN (Pump, Infusion)
- 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
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. The FDA summary names its predicate without a number.
- (no number) IPI AlgoLine™ Catheter Kits: named in the summary without a submission number

## Indications for use
The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions. The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions. The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.

Source page: https://510kreport.com/device/K955180
Methodology: https://510kreport.com/methodology