510(k) · Cleared
Recalled · Class II · 2023FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Oct 29, 2015 as substantially equivalent to K972579 (Baxter Healthcare Corp, 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Oct 29, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895631 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK895631 Disconnect Caps Product Codes 5C4212 and 5C4466Baxter Healthcare Corp · 1990 · Recalled
- 1 generation backK972579 High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose…Baxter Healthcare Corp · 1997
- This deviceK152129 FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with…Baxter Healthcare Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466 | Baxter Healthcare Corp | 1990 | 4 |
| −1 | K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose… | Baxter Healthcare Corp | 1997 | — |
| 0 (this device) | K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with… | Baxter Healthcare Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with…Summary page 6…evice Device Company Predicate 510(k) Clearance Date High Dose Disconnect Cap and MiniCap Baxter Healthcare K972579 October 1, 1997 with Povidone-Iodine, High Dose Disconnect Corporation Cap with Povidone-Iodine DESCRIPTION OF THE… | 1997 |
| * | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466Summary page 9…e 2. Predicate Device Device Company Predicate 510(k) Clearance Date Disconnect Caps Product Codes Baxter Healthcare K895631 January 29, 1990 5C4212 and 5C4466 Corporation DESCRIPTION OF THE DEVICE: The MiniCap with Povidone-… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2023 | Class II | Z-1213-2023 | Process control | MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 18.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K972579.
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. 2015, this device’s year, is highlighted.
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?
This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient line connector of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy.
This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152129: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152129
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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