# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Ads, Inc.
- Decided: Aug 24, 2017 after 143 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960826 (1996). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
5 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130394: Cadd -Solis Ambulatory Infusion Pump, Version 3.0, Smiths Medical Asd, Inc. (2013) Summary page 4.
- K040636: Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set, Smiths Medical MD, Inc. (2004) Summary page 4.

## Most influential descendants
- 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-1681-2025: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- 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
- Apr 10, 2025 · Class I · Z-1662-2025: Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Jun 26, 2024 · Class II · Z-0466-2025: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate fr
- Feb 27, 2024 · Class I · Z-2420-2024: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarach
- Dec 9, 2022 · Class I · Z-0963-2023: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

## Indications for use
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication CADD®-Solis Infusion Pump, Model 2110 The CADD®-Solis Pump 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. 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. PharmGuard® Administrator Medication Safety Software The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump. CADD® Administration Set The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. Wireless Communication Module (CM) The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110

Source page: https://510kreport.com/device/K170982
Methodology: https://510kreport.com/methodology