# K982838: Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Nov 4, 1998 after 84 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.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices 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) CADD-1® Ambulatory Infusion Pump: named in the summary without a submission number
- (no number) CADD-Prizm® VIP Model 6100 Ambulatory Infusion System: named in the summary without a submission number

## Most influential descendants
- K013234: Microjet Crono (2002), 6 descendants of its own
- K041414: Crono and Crono, Model 30 (2004), 5 descendants of its own
- K052218: Crono Five and Crono Pca 50 (2005), 2 descendants of its own
- K052217: Crono Super Pid (2005), 2 descendants of its own
- K091042: Crono S-Pid 50 (2009), 1 descendant of its own

## Recalls of this device
- Nov 22, 2017 · Class II · Z-0307-2018: Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial nu
- Dec 23, 2009 · Not classified · Z-1235-2010: The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. I

## Indications for use
The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion.

Source page: https://510kreport.com/device/K982838
Methodology: https://510kreport.com/methodology