# K192705: MiniCap Extended Life PD Transfer Sets

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare
- Decided: Oct 25, 2019 after 28 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882498 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152675: Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter, Baxter Healthcare (2015) Summary page 5.

## Recalls of this device
- Oct 23, 2024 · Class II · Z-0562-2025: 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-0376-2025: 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
- Nov 10, 2020 · Class II · Z-0768-2021: Potential for no-flow and leaks under the twist clamp.

## 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.

Source page: https://510kreport.com/device/K192705
Methodology: https://510kreport.com/methodology