510(k) · Cleared
Recalled · Class I · 2025Cadd -Solis Ambulatory Infusion Pump, Version 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · MEA Pump, Infusion, Pca
Cleared on Dec 9, 2013 as substantially equivalent to K072144 (Smiths Medical MD, Inc., 2008) and 1 other predicate after a 297-day review. Its family tree reaches back 2 generations to 1996. 4 of the 9 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Dec 9, 2013
- Review
- 297 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960826 (1996). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK960826 Cadd-Prizm Model 6100 PumpSims Deltec, Inc. · 1996 · Recalled
- 1 generation backK111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication…Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- This deviceK130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK170982 CADD®- Solis Ambulatory Infusion Pump with Wireless Communication…Smiths Medical Ads, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK232793 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK242660 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK213744 Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…Smiths Medical Ads, Inc. · 2017 · cites it directly3descendants
- K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 2 generations on1descendant
- K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 3 generations on0descendants
- K213744Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960826 | Cadd-Prizm Model 6100 Pump | Sims Deltec, Inc. | 1996 | 1 |
| −1 | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety… | Smiths Medical Asd, Inc. | 2013 | Class I |
| 0 (this device) | K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0 | Smiths Medical Asd, Inc. | 2013 | — |
| +1 | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis… | Smiths Medical Ads, Inc. | 2017 | Class I |
| +2 | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| +3 | K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| +2 | K213744 | Avoset Infusion Pump System | Eitan Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 1 |
| 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.
4 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? (4)
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 |
|---|---|---|---|
| * | K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…Summary page 1…Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASO. Inc. CADD®-Sois Ambulatory Infusion Pump, Version 1.0 (K072 144) and CADD®-Solis VIP Ambulatory Infusion Pump, Version 2.0 (K 111275). The user activates CADD®-Solis Version 3.0 Pump via a colo… | 2008 |
| * | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSummary page 1…similar in design to the Smiths Medical ASO. Inc. CADD®-Sois Ambulatory Infusion Pump, Version 1.0 (K072 144) and CADD®-Solis VIP Ambulatory Infusion Pump, Version 2.0 (K 111275). The user activates CADD®-Solis Version 3.0 Pump via a color LCD screen and keypad user interface. Commands are issued to the mi… | 2013 |
| * | — | CADD-Solis Medication Safety Software, Version 1.2 Named without a submission number | |
| * | — | CADD-Solis Medication Safety Software, Version 2.0 Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion… Class I | 2017 | 3 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| May 26, 2015 | Class II | Z-1813-2015 | Nonconforming Material/Component | 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 the CADD¿-Solis Medication Cassette… |
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.
- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · Direct predicate · ◆ 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 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K170982 (Smiths Medical Ads, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K072144.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
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…
Read the full statement (141 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130394: Cadd -Solis Ambulatory Infusion Pump, Version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130394
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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