510(k) · Cleared
Recalled · Class I · 2025Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · MEA Pump, Infusion, Pca
Cleared on Mar 7, 2008 after a 218-day review. The FDA summary names its predicate without a number. 6 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 7 times, including 2 Class I recalls.
- Decided
- Mar 7, 2008
- Review
- 218 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 7 (2 Class I)
- Predicates
- 0
8 later devices descend from it, 2 citing it directly. 6 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK072144 Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication…Smiths Medical MD, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication…Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd…cites it directly · 2013
- K130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0cites it directly · 2013
- K153193 Halo II Ambulatory Infusion System (also with…2 generations on · 2016
- K140783 Halo Ambulatory Infusion System2 generations on · 2014
Most influential descendants
Showing 5 of 8 · See all- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · cites it directly7descendants
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · cites it directly4descendants
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…Smiths Medical Ads, Inc. · 2017 · 2 generations on3descendants
- K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 2 generations on1descendant
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety… | Smiths Medical MD, Inc. | 2008 | — |
| +1 | 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 |
| +2 | 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 | — |
| +2 | K140783 | Halo Ambulatory Infusion System | Zyno Medical, LLC | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 2 |
| 2014 | 1 | 1 |
| 2016 | 1 | 1 |
| 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.
6 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 |
|---|---|---|---|
| * | — | CADD-Prizm® PCS II Model 6101 Ambulatory Infusion System Named without a submission number | |
| * | — | CADD-Sentry Pro® Medication Safety Named without a submission number |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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. |
| Feb 27, 2024 | Class I | Z-2419-2024 | Software Manufacturing/Software Deployment | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error… |
| 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… |
| Sep 29, 2014 | Class II | Z-0166-2015 | Process control | Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis… |
| May 10, 2011 | Not classified | Z-0004-2012 | Nonconforming Material/Component | Reports of non-delivery/ significant under-delivery of fluids when the CADD Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with… |
| Jan 13, 2011 | Not classified | Z-1033-2011 | Nonconforming Material/Component | Reports of the Cassette Lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock… |
| Jan 27, 2010 | Not classified | Z-1082-2010 | Nonconforming Material/Component | Potential for the power cord's prongs to crack and fail at/or inside the plug. Other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths… |
The 5 latest of 7 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.
- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · 2 generations on · ◆ in the 2014 descendants 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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
- Of its descendants, K111275 (Smiths Medical Asd, Inc., 2013) has gone furthest, with 7 descendants 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. 2008, 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 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, patient-controlled demand doses, or both (such as patient-controlled analgesia). The CADD®-Solis Medication…
Read the full statement (122 words)
The CADD®-Solis ambulatory infusion 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 infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patient-controlled analgesia).
The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072144: Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072144
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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