# K082783: Cadd -Solis Medication Safety Software:  Administrator and Point-of-Care

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Dec 17, 2008 after 85 days
- Product code: MRZ (Accessories, 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.
8 later devices descend from it; 1 cites it directly.
5 of 9 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®-Solis Medication Safety Software: named in the summary without a submission number
- (no number) CADD-Sentry Pro™ Medication Safety Software: named in the summary without a submission number

## Most influential descendants
- K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software (2013), 7 descendants of its own
- K130394: Cadd -Solis Ambulatory Infusion Pump, Version 3.0 (2013), 4 descendants of its own
- K170982: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (2017), 3 descendants of its own
- K232793: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (2024), 1 descendant of its own
- K140783: Halo Ambulatory Infusion System (2014), 1 descendant of its own

## Indications for use
The CADD®-Solis Medication Safety Software - Administrator allows use of a computer to create therapy based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump or CADD-Prizm ® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD®-Solis Medication Safety Software - Point of Care allows use of a computer to send therapy-based protocols developed by the CADD®-Solis Medication Safety Software - Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

Source page: https://510kreport.com/device/K082783
Methodology: https://510kreport.com/methodology