# K970648: Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)

- Pathway: 510(k) (Traditional)
- Applicant: Renal Systems, Inc.
- Decided: Jan 5, 1998 after 319 days
- Product code: MSF (Hemodialyzer, Re-Use, High Flux)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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
The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse.

Source page: https://510kreport.com/device/K970648
Methodology: https://510kreport.com/methodology