510(k) · Cleared
Recalled · 2007Cadd-Prizm PCS II Model 6101 Ambulatory Infusion System
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 Jun 8, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 8, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 0
16 later devices descend from it, 2 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- This deviceK000842 Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSims Deltec, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- Descendant · 3 generations on · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- Descendant · 3 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · cites it directly7descendants
- K042228Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004 · cites it directly7descendants
- K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005 · 2 generations on6descendants
- K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · 3 generations on5descendants
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion System | Sims Deltec, Inc. | 2000 | — |
| +1 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +1 | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| +2 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| +3 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| +3 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 1 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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? (2 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… |
| Jun 23, 2003 | Not classified | Z-0980-03 | Other | Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage. |
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.
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K123049 (Q Core Medical, Ltd., 2013) has gone furthest, with 7 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) | — |
https://510kreport.com/device/K000842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000842: Cadd-Prizm PCS II Model 6101 Ambulatory Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000842
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026