# K994218: Easy Care and Tubing Sets

- Pathway: 510(k) (Special)
- Applicant: Medionics International, Inc.
- Decided: Feb 10, 2000 after 57 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- 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 K910173 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910173: Selectra and Tubing Sets, Medionics International, Ltd. (1992) Summary page 2.

## Indications for use
Easy Care and Tubing Sets are used to provide peritoneal dialysis fluid exchanges for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in and out of the peritoneal cavity of the patient by means of gravity.

Source page: https://510kreport.com/device/K994218
Methodology: https://510kreport.com/methodology