510(k) · Cleared
ClearedCadd -Solis Medication Safety Software: Administrator and Point-of-Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Dec 17, 2008 after an 85-day review. The FDA summary names its predicate without a number. 5 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Dec 17, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 5 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK082783 Cadd -Solis Medication Safety Software: Administrator and…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 · 2 generations on · 4 of its ownK130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- Descendant · 3 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
- K153193 Halo II Ambulatory Infusion System (also with…2 generations on · 2016
- K130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.02 generations on · 2013
- 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 · 2 generations on4descendants
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…Smiths Medical Ads, Inc. · 2017 · 3 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) | K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-of-Care | 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 |
| +2 | K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0 | Smiths Medical Asd, Inc. | 2013 | Class I |
| +3 | 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.
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.
Top candidate predicates for a new MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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®-Solis Medication Safety Software Named without a submission number | |
| * | — | CADD-Sentry Pro™ Medication Safety Software Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software Class I | 2013 | 7 |
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
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
- 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
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- 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 · 3 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 MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 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 as stated in the FDA summary.
https://510kreport.com/device/K082783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082783: Cadd -Solis Medication Safety Software: Administrator and Point-of-Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082783
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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