# K993149: Peritoneal Dialysis Catheters and Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Medionics International, Inc.
- Decided: Apr 28, 2000 after 220 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Peritoneal Dialysis Catheters and Adapters are access devices used for providing peritomneal dialysis treatmaent for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in a consistent manner, without requiring extraordinary effort or causing discomfort.

Source page: https://510kreport.com/device/K993149
Methodology: https://510kreport.com/methodology