# K062592: Cadd-Sentry Pro Medication Safety Software

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Nov 29, 2006 after 89 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) CADD-Diplomat® PC Communications System: named in the summary without a submission number
- (no number) Medley™ Medication Safety System: named in the summary without a submission number
- (no number) Medley™ System with Bar Code Module: named in the summary without a submission number

## Indications for use
The CADD-Sentry Pro Medication Safety Software - Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD-Sentry Pro Medication Safety Software - Point of Care allows use of a personal computer to send CADD-Sentry Pro Medication Safety Software - Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

Source page: https://510kreport.com/device/K062592
Methodology: https://510kreport.com/methodology