510(k) · Cleared
ClearedCadd-Legacy Pca Ambulatory Infusion System, Model 6300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Deltec, Inc. · MEA Pump, Infusion, Pca
Cleared on Nov 2, 1998 after an 82-day review. The FDA summary names its predicate without a number. 2 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Nov 2, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- MEA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- This deviceK982839 Cadd-Legacy Pca Ambulatory Infusion System, Model 6300Sims Deltec, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK153193 Halo II Ambulatory Infusion System (also with trade names Nimbus II…Zyno Medical, LLC · 2016 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK013822 Microjet Crono PcaCane S.R.L. · 2002
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · cites it directly1descendant
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC · 2016 · 2 generations on0descendants
- K013822Microjet Crono PcaCane S.R.L. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982839 | Cadd-Legacy Pca Ambulatory Infusion System, Model 6300 | Sims Deltec, Inc. | 1998 | — |
| +1 | K140783 | Halo Ambulatory Infusion System | Zyno Medical, LLC | 2014 | Class I |
| +2 | K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory… | Zyno Medical, LLC | 2016 | Class I |
| +1 | K013822 | Microjet Crono Pca | Cane S.R.L. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 1 | 1 |
| 2016 | 1 | 1 |
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.
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.
- 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-PCA® 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? (3)
2 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)
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.
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 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
What does this lineage say?
- Of its descendants, K140783 (Zyno Medical, LLC, 2014) has gone furthest, with 1 descendant 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.
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-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/K982839 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982839: Cadd-Legacy Pca Ambulatory Infusion System, Model 6300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982839
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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