# K051568: Cadd-MS 3 Ambulatory Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Nov 17, 2005 after 156 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 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-Micro® Ambulatory Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K190182: Unity Subcutaneous Delivery System for Remodulin (2019), 7 descendants of its own
- K191313: Unity Subcutaneous Infusion System for Remodulin (2020), 3 descendants of its own
- K241736: Remunity 2.0 Pump for Remodulin (treprostinil) Injection (2025), 2 descendants of its own
- K250357: RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (2025), 1 descendant of its own
- K202690: Remunity Pump for Remodulin (treprostinil) Injection (2020), 1 descendant of its own

## Recalls of this device
- Mar 7, 2008 · Not classified · Z-1621-2008: Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of med
- Feb 22, 2008 · Not classified · Z-1641-2008: Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" wi

## Indications for use
"The CADD-MS TM 3 Ambulatory Infusion Pump is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication." "The Smiths Medical MD, Inc, 3-ml Cartridge Reservoir is designed for use with the CADD-MS" 3 for delivering medication."

Source page: https://510kreport.com/device/K051568
Methodology: https://510kreport.com/methodology