# K973917: Cadd-Diplomat PC Communications System and the Cadd- Ambassador Pump Communications System

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Jan 9, 1998 after 86 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Sabratek’s MediVIEW™ Software Package used with their Homerun™ Model 6060 Ambulatory Infusion Pump: named in the summary without a submission number
- (no number) The current Modem used with SIMS Deltec’s CADD-Prizm™ Model 6100 Ambulatory Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K020655: Deltec Insulin Infusion Pump and Accessories (2002), 0 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

## Indications for use
To allow communication between a personal computer and the CADD-Prizm™ Ambulatory Infusion Pump, Model 6100, or pump-to-pump, either remotely or locally via a modem over telephone lines.

Source page: https://510kreport.com/device/K973917
Methodology: https://510kreport.com/methodology