510(k) · Cleared
Recalled · Class I · 2025CADD®- 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Ads, Inc. · MEA Pump, Infusion, Pca
Cleared on Aug 24, 2017 as substantially equivalent to K130394 (Smiths Medical Asd, Inc., 2013) and 1 other predicate after a 143-day review. Its family tree reaches back 3 generations to 1996. 5 of the 10 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 6 times, including 5 Class I recalls.
- Decided
- Aug 24, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 6 (5 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960826 (1996). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly. 5 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK960826 Cadd-Prizm Model 6100 PumpSims Deltec, Inc. · 1996 · Recalled
- 2 generations backK111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication…Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- 1 generation backK130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- This deviceK170982 CADD®- Solis Ambulatory Infusion Pump with Wireless Communication…Smiths Medical Ads, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK232793 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242660 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK213744 Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023
Class I recalls in this family
- K130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0direct predicate · 2013
- K040636 Cadd Administration Set with Flow Stop…direct predicate · 2004
- K111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd…2 generations back · 2013
- K072144 Cadd -Solis Ambulatory Infusion Pump and Cadd…2 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · cites it directly1descendant
- K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 2 generations on0descendants
- K213744Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960826 | Cadd-Prizm Model 6100 Pump | Sims Deltec, Inc. | 1996 | 1 |
| −2 | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety… | Smiths Medical Asd, Inc. | 2013 | Class I |
| −1 | K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0 | Smiths Medical Asd, Inc. | 2013 | Class I |
| 0 (this device) | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis… | Smiths Medical Ads, Inc. | 2017 | — |
| +1 | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| +2 | K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| +1 | K213744 | Avoset Infusion Pump System | Eitan Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2008 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0Summary page 4…PYR– Neuraxial Administration Set - Intrathecal delivery Device Class: Class II Primary Predicate Device: K130394 Secondary Predicate Device: K040636 Device Description The CADD®- Solis Ambulatory Infusion Pump with Wireless Comm… | 2013 |
| * | K040636 | Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and…Summary page 4…n Set - Intrathecal delivery Device Class: Class II Primary Predicate Device: K130394 Secondary Predicate Device: K040636 Device Description The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusio… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2025 | Class I | Z-1681-2025 | Under Investigation by firm | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| Apr 10, 2025 | Class I | Z-1667-2025 | Labeling design | 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 injury or death. |
| Apr 10, 2025 | Class I | Z-1662-2025 | Software design | 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 | Device Design | 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 from the input plug. |
| Feb 27, 2024 | Class I | Z-2420-2024 | Software Manufacturing/Software Deployment | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. |
| Dec 9, 2022 | Class I | Z-0963-2023 | Under Investigation by firm | 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 |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K040636Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 6 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K232793 (Zevex, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (152 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170982 · printed Nov 5, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170982
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026