# K130394: Cadd -Solis Ambulatory Infusion Pump, Version 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Dec 9, 2013 after 297 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960826 (1996). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
4 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072144: Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator, Smiths Medical MD, Inc. (2008) Summary page 1.
- K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software, Smiths Medical Asd, Inc. (2013) Summary page 1.
- (no number) CADD-Solis Medication Safety Software, Version 1.2: named in the summary without a submission number
- (no number) CADD-Solis Medication Safety Software, Version 2.0: named in the summary without a submission number

## Most influential descendants
- 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
- K242660: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (2024), 0 descendants of its own
- K213744: Avoset Infusion Pump System (2023), 0 descendants of its own

## Recalls of this device
- Apr 10, 2025 · Class I · Z-1667-2025: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient
- May 26, 2015 · Class II · Z-1813-2015: Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD¿-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching 

## Indications for use
The CADD-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses. 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 VIP Ambulatory Infusion Pump, 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/K130394
Methodology: https://510kreport.com/methodology