# K000842: Cadd-Prizm PCS II Model 6101 Ambulatory Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Jun 8, 2000 after 85 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.
16 later devices descend from it; 2 cite it directly.
2 of 17 devices 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.

## Most influential descendants
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own
- K042228: Beeline Motiv, Propolis, Pca (2004), 7 descendants of its own
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit (2005), 6 descendants of its own
- K052451: MPS Acacia Medflo Elastomeric Pump (2005), 5 descendants of its own
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump (2008), 4 descendants of its own

## Recalls of this device
- Jan 19, 2007 · Not classified · Z-0718-2007: The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immedia
- Jun 23, 2003 · Not classified · Z-0980-03: Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.

Source page: https://510kreport.com/device/K000842
Methodology: https://510kreport.com/methodology