# K990159: Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111

- Pathway: 510(k) (Traditional)
- Applicant: Dynamic Technology Corp.
- Decided: Apr 19, 1999 after 90 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
Longest line of descent: 2 generations back to K864831 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914790: Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-R, National Medical Care, Medical Products Div., Inc. (1993) Summary page 1.
- K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber, Gambro, Inc. (1990) Summary page 1.
- K973291: Dynamic Hollow Fiber Dialyzer DC-Series, Dynamic Technology Corp. (1997) Summary page 2.

## Indications for use
The DYNAMIC Hollow Fiber Dialyzer DH-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient’s illness.

Source page: https://510kreport.com/device/K990159
Methodology: https://510kreport.com/methodology