# K961825: Ultraset/3L Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 6, 1996 after 88 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883239 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902526: Capd Disposable Disconnect Y-Set Code: 5C4481, Baxter Healthcare Corp (1990) Summary page 1.
- K883239: Capd Ultraviolet (U.V.) Germicidal Exchange Dev Sys, Baxter Healthcare Corp (1988) Summary page 1.

## Indications for use
The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange.

Source page: https://510kreport.com/device/K961825
Methodology: https://510kreport.com/methodology