# K152675: Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare
- Decided: Oct 29, 2015 after 41 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 13 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882498 (1988). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882498: Extended Life Capd Transfer Set 5C4444, Baxter Healthcare Corp (1988) Summary page 6.
- K894783: Peritoneal Dial. Tita. Cath Adapter & Locking Cap, Baxter Healthcare Corp (1989) Summary page 9.

## Most influential descendants
- K231849: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (2024), 0 descendants of its own
- K192705: MiniCap Extended Life PD Transfer Sets (2019), 0 descendants of its own

## Recalls of this device
- Oct 23, 2024 · Class II · Z-0559-2025: 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: 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 (P
- Jan 7, 2022 · Class II · Z-0573-2022: 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 d
- Jan 7, 2022 · Class II · Z-0575-2022: 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 d
- Jan 7, 2022 · Class II · Z-0578-2022: 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 d
- Jan 7, 2022 · Class II · Z-0580-2022: 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 d
- Jan 7, 2022 · Class II · Z-0570-2022: 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 d
- Jan 7, 2022 · Class II · Z-0574-2022: 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 d
- Jan 7, 2022 · Class II · Z-0579-2022: 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 d
- Jan 7, 2022 · Class II · Z-0572-2022: 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 d
- Jan 7, 2022 · Class II · Z-0576-2022: 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 d
- Jan 7, 2022 · Class II · Z-0577-2022: 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 d
- Jan 7, 2022 · Class II · Z-0571-2022: 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 d

## Indications for use
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.

Source page: https://510kreport.com/device/K152675
Methodology: https://510kreport.com/methodology