510(k) · Cleared
Recalled · Class II · 2017Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400
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 Nov 4, 1998 after an 84-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 4, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK982838 Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK013234 Microjet CronoCane S.R.L. · 2002
- Descendant · 2 generations on · 5 of its ownK041414 Crono and Crono, Model 30Cane S.R.L. · 2004 · Recalled
- Descendant · 3 generations on · 2 of its ownK052218 Crono Five and Crono Pca 50Cane S.R.L. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK052217 Crono Super PidCane S.R.L. · 2005 · Recalled
- Descendant · 4 generations on · 1 of its ownK091042 Crono S-Pid 50Cane S.R.L. · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K013234Microjet CronoCane S.R.L. · 2002 · cites it directly6descendants
- K041414Crono and Crono, Model 30Cane S.R.L. · 2004 · 2 generations on5descendants
- K052218Crono Five and Crono Pca 50Cane S.R.L. · 2005 · 3 generations on2descendants
- K052217Crono Super PidCane S.R.L. · 2005 · 3 generations on2descendants
- K091042Crono S-Pid 50Cane S.R.L. · 2009 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400 | Sims Deltec, Inc. | 1998 | — |
| +1 | K013234 | Microjet Crono | Cane S.R.L. | 2002 | — |
| +2 | K041414 | Crono and Crono, Model 30 | Cane S.R.L. | 2004 | 1 |
| +3 | K052218 | Crono Five and Crono Pca 50 | Cane S.R.L. | 2005 | 1 |
| +3 | K052217 | Crono Super Pid | Cane S.R.L. | 2005 | 1 |
| +4 | K091042 | Crono S-Pid 50 | Cane S.R.L. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
| 2025 | 1 | 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.
Planning a device in FRN? 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 |
|---|---|---|---|
| * | — | CADD-1® Ambulatory Infusion Pump Named without a submission number | |
| * | — | CADD-Prizm® VIP Model 6100 Ambulatory Infusion System Named without a submission number |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2017 | Class II | Z-0307-2018 | Process design | Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of… |
| Dec 23, 2009 | Not classified | Z-1235-2010 | Employee error | The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013234 (Cane S.R.L., 2002) has gone furthest, with 6 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 CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion.
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/K982838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982838: Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982838
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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