# K980658: PSN Dialyzer, Model PSN 130/R5M4233, Model PSN-150/R5M4234

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 19, 1998 after 89 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- 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
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) CA® Hollow Fiber Dialyzers: named in the summary without a submission number
- (no number) Baxter predicate Dialyzers: named in the summary without a submission number

## Indications for use
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.

Source page: https://510kreport.com/device/K980658
Methodology: https://510kreport.com/methodology