# K963668: Medisystems Peritoneal Dialysis Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Aug 15, 1997 after 336 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Peritoneal Dialysis Sets manufactured by Fresenius USA: named in the summary without a submission number

## Indications for use
Medisystems Peritoneal Dialysis Set product line is indicated for use in compatible peritoneal dialysis procedures. Specific codes are indicated respectively for Continuous Ambulatory Peritoneal Dialysis (CAPD) and Cycler Peritoneal Dialysis.

Source page: https://510kreport.com/device/K963668
Methodology: https://510kreport.com/methodology