# K011148: Ultraconcentrator System

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Jun 13, 2001 after 58 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022348: Access Concentration System, Model Acc-100, Access  Disposable Set, Model Ads-2000 (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K011148
Methodology: https://510kreport.com/methodology