510(k) · Cleared
Recalled · 2007Cadd-Prizm Model 6100 Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Deltec, Inc. · FRN Pump, Infusion
Cleared on Aug 23, 1996 after a 176-day review. The FDA summary names its predicate without a number. 6 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled once.
- Decided
- Aug 23, 1996
- Review
- 176 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 2 citing it directly. 6 of the 17 devices in this family, counting this one, have a Class I recall.
- This deviceK960826 Cadd-Prizm Model 6100 PumpSims Deltec, Inc. · 1996
- Descendant · cites it directly · 8 of its ownK082182 AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008
- Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- 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)
Showing 5 of 16 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 16 · See all- K082182AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008 · cites it directly8descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960826 | Cadd-Prizm Model 6100 Pump | Sims Deltec, Inc. | 1996 | — |
| +1 | K082182 | AP 34 Multi-Therapy Infusion Pump | Q-Core, Ltd. | 2008 | — |
| +2 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 3 | 2 |
| 2014 | 3 | 1 |
| 2016 | 2 | 1 |
| 2017 | 3 | 1 |
| 2020 | 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.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | — | Abbott Laboratories AIM™ System Named without a submission number | |
| * | — | Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System) Named without a submission number |
What descends from it? (16)
See all 162 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 |
|---|---|---|---|---|
| Jan 19, 2007 | Not classified | Z-0718-2007 | Other | The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service… |
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
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K082182 (Q-Core, Ltd., 2008) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings.
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/K960826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960826: Cadd-Prizm Model 6100 Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960826
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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