510(k) · Cleared
ClearedUltraset/3L Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Aug 6, 1996 as substantially equivalent to K902526 (Baxter Healthcare Corp, 1990) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 6, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883239 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK883239 Capd Ultraviolet (U.V.) Germicidal Exchange Dev SysBaxter Healthcare Corp · 1988 · Recalled
- This deviceK961825 Ultraset/3L Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493Baxter Healthcare Corp · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883239 | Capd Ultraviolet (U.V.) Germicidal Exchange Dev Sys | Baxter Healthcare Corp | 1988 | 1 |
| 0 (this device) | K961825 | Ultraset/3L Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493 | Baxter Healthcare Corp | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 KDJ? 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 KDJ device
- #1 K250404 stay•safe® catheter extension set with Safe-…score 9.4 · 2 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 |
|---|---|---|---|
| * | K902526 | Capd Disposable Disconnect Y-Set Code: 5C4481Summary page 1…Y-Sets with solution drainage bag for Peritoneal Dialysis (PD) Peritoneal dialysis system and accessories per 21 CFR 876.5630 Baxter CAPD Disposable Disconnect Y-Set (K902526) and UV-III Disposable Disconnect Y-Set (K883239). The Y-shaped design of the set enables patients to initially drain the dialys… | 1990 |
| * | K883239 | Capd Ultraviolet (U.V.) Germicidal Exchange Dev SysSummary page 1…Dialysis (PD) Peritoneal dialysis system and accessories per 21 CFR 876.5630 Baxter CAPD Disposable Disconnect Y-Set (K902526) and UV-III Disposable Disconnect Y-Set (K883239). The Y-shaped design of the set enables patients to initially drain the dialysis solution from the peritoneum into the attached… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All KDJ devicesKDJ Set, Administration, For Peritoneal Dialysis, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDJ
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDJ
21in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDJ
2,460in 2025
MAUDE reports naming product code KDJ, 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 | 219 |
| 2008 | 1 | — | 0 | 411 |
| 2009 | 0 | — | 2 | 233 |
| 2010 | 0 | — | 0 | 1,879 |
| 2011 | 0 | — | 0 | 4,315 |
| 2012 | 0 | — | 0 | 4,294 |
| 2013 | 1 | — | 1 | 5,623 |
| 2014 | 0 | — | 0 | 7,680 |
| 2015 | 2 | — | 1 | 6,870 |
| 2016 | 1 | — | 0 | 7,045 |
| 2017 | 0 | — | 0 | 4,636 |
| 2018 | 3 | 90 | 0 | 3,379 |
| 2019 | 1 | — | 0 | 2,456 |
| 2020 | 0 | — | 1 | 2,870 |
| 2021 | 0 | — | 0 | 3,167 |
| 2022 | 1 | — | 12 | 2,927 |
| 2023 | 0 | — | 1 | 2,947 |
| 2024 | 1 | — | 21 (10) | 3,113 |
| 2025 | 1 | — | 0 | 2,460 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange.
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/K961825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961825: Ultraset/3L Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961825
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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