510(k) · Cleared
ClearedHigh Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine
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 Oct 1, 1997 as substantially equivalent to K895631 (Baxter Healthcare Corp, 1990) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Oct 1, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895631 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK895631 Disconnect Caps Product Codes 5C4212 and 5C4466Baxter Healthcare Corp · 1990 · Recalled
- This deviceK972579 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 2 of 2 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466 | Baxter Healthcare Corp | 1990 | 4 |
| 0 (this device) | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466Summary page 1…for Peritoneal Dialysis (PD) therapy Peritoneal dialysis system and accessories per 21 CFR 876.5630 Baxter's Easy Lock™ Disconnect Cap with Povidone-lodine Solution ( K895631), Baxter's disconnect MiniCap with Povidone-lodine Solution ( K895631), and the Medionics QC Cap (K945567) The High Dose Disconn… | 1990 |
| * | K945567 | QC CAPSummary page 1…ter's Easy Lock™ Disconnect Cap with Povidone-lodine Solution ( K895631), Baxter's disconnect MiniCap with Povidone-lodine Solution ( K895631), and the Medionics QC Cap (K945567) The High Dose Disconnect Cap and MiniCap with Povidone- Iodine Solution (5C4486) consists of the High Dose Disconnect Cap, whic… | 1995 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) are single use caps that are intended for use with appropriate Peritoneal Dialysis (PD) products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set. The MiniCap is designed to isolate (cap off) the Easy-Lock™ connector of the patient's transfer set.
The High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) is a single use cap that is intended for use with appropriate Peritoneal Dialysis (PD) disposable products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set.
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/K972579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972579: High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972579
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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