# K943310: Model 6100 Ambulatory Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Deltec, Inc.
- Decided: Feb 21, 1995 after 225 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K991599: Cadd Administration Set (1999), 0 descendants of its own
- K991301: Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon Valve, Cadd Administration Set with 1 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K943310
Methodology: https://510kreport.com/methodology