510(k) · Cleared
Recalled · Class I · 2024Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Oct 29, 2015 as substantially equivalent to K882498 (Baxter Healthcare Corp, 1988) and 1 other predicate after a 41-day review. Its family tree reaches back 1 generation to 1988. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 13 times, including a Class I recall.
- Decided
- Oct 29, 2015
- Review
- 41 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 13 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882498 (1988). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK882498 Extended Life Capd Transfer Set 5C4444Baxter Healthcare Corp · 1988 · Recalled
- This deviceK152675 Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium…Baxter Healthcare · 2015
- Descendant · cites it directly · 0 of its ownK231849 MiniCap Extended Life PD Transfer Set with Twist Clamp - Code…Baxter Healthcare · 2024
- Descendant · cites it directly · 0 of its ownK192705 MiniCap Extended Life PD Transfer SetsBaxter Healthcare · 2019 · Recalled (Class I)
Class I recalls in this family
- K192705 MiniCap Extended Life PD Transfer Setscites it directly · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882498 | Extended Life Capd Transfer Set 5C4444 | Baxter Healthcare Corp | 1988 | 7 |
| 0 (this device) | K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter… | Baxter Healthcare | 2015 | — |
| +1 | K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap… | Baxter Healthcare | 2024 | — |
| +1 | K192705 | MiniCap Extended Life PD Transfer Sets | Baxter Healthcare | 2019 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 1 |
| 2024 | 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.
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.
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 |
|---|---|---|---|
| * | K882498 | Extended Life Capd Transfer Set 5C4444Summary page 6…edicate Device(s) Device Company Predicate 510(k) Clearance Date Extended Life CAPD Baxter Healthcare K882498 07/13/1988 Transfer Set 5C4444 Corporation DESCRIPTION OF THE DEVICE: The MiniCap Extended L… | 1988 |
| * | K894783 | Peritoneal Dial. Tita. Cath Adapter & Locking CapSummary page 9…le 2. Predicate Device(s) Device Company Predicate 510(k) Clearance Date Peritoneal Dialysis Baxter Healthcare K894783 September 7, 1989 Titanium Catheter Corporation Adapter and Locking Cap for Titanium Adapter – Produc… | 1989 |
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? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2024 | Class II | Z-0559-2025 | Under Investigation by firm | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| Oct 21, 2024 | Class I | Z-0373-2025 | Nonconforming Material/Component | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal… |
| Jan 7, 2022 | Class II | Z-0573-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0575-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0578-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0580-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0570-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0574-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0579-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0572-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0576-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0577-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
| Jan 7, 2022 | Class II | Z-0571-2022 | Other | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to… |
The 5 latest of 13 recalls; the web page lists all.
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.
- K192705MiniCap Extended Life PD Transfer SetsBaxter Healthcare · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K231849 (Baxter Healthcare, 2024) has gone furthest, with 0 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. 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 set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.
Titanium Adapter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy.
Locking Cap: This device is indicated for use in the treatment of patients receiving peritoneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter between Baxter Transfer Set installations.
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/K152675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152675: Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152675
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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