# K971860: Medisystems Dialysis Priming Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Aug 18, 1997 after 90 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K811837 (1981). 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)
- K811837: I.V. Administration Set, Medisystems Corp. (1981) Summary page 1.
- K895882: JMS Dialyzer Priming Set, Jms Co., Ltd. (1990) Summary page 1.

## Indications for use
The proposed Dialysis Priming Sets are indicated for use to provide a means to deliver fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures.

Source page: https://510kreport.com/device/K971860
Methodology: https://510kreport.com/methodology