510(k) · Cleared
Recalled · Class II · 2015Disconnect Caps Product Codes 5C4212 and 5C4466
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 Jan 29, 1990 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 29, 1990
- Review
- 132 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 4
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK895631 Disconnect Caps Product Codes 5C4212 and 5C4466Baxter Healthcare Corp · 1990
- Descendant · cites it directly · 2 of its ownK972579 High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose…Baxter Healthcare Corp · 1997
- Descendant · cites it directly · 0 of its ownK152129 FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with…Baxter Healthcare Corporation · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK031676 Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q…Baxter Healthcare Corp · 2003 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K972579High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with…Baxter Healthcare Corp · 1997 · cites it directly2descendants
- K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…Baxter Healthcare Corporation · 2015 · cites it directly0descendants
- K031676Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q…Baxter Healthcare Corp · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466 | Baxter Healthcare Corp | 1990 | — |
| +1 | K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose… | Baxter Healthcare Corp | 1997 | — |
| +1 | K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with… | Baxter Healthcare Corporation | 2015 | 1 |
| +1 | K031676 | Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q… | Baxter Healthcare Corp | 2003 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2015 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with… | 1997 | 2 |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine… | 2015 | 0 |
| K031676 | Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q… | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2015 | Class II | Z-1269-2015 | Under Investigation by firm | Product may have separating or protruding sponges |
| Jun 17, 2014 | Class II | Z-2074-2014 | Packaging process control | Inadequate iodine and packaging related defects. |
| Jul 8, 2013 | Class II | Z-1945-2014 | Packaging change control | the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging. |
| May 21, 2013 | Class II | Z-1565-2013 | Packaging change control | leaking pouches |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972579 (Baxter Healthcare Corp, 1997) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K895631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895631: Disconnect Caps Product Codes 5C4212 and 5C4466.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895631
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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