# K963933: PSN-120 Hollow Fiber Dialyzer and PSN-140 Hollow Fiber Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 24, 1997 after 419 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) CF Capillary Flow Dialyzers: named in the summary without a submission number
- (no number) CA Cellulose Acetate Hollow Fiber Dialyzers: named in the summary without a submission number
- (no number) HT Hollow Fiber 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/K963933
Methodology: https://510kreport.com/methodology