# K981253: Ultracon Ultrafiltrator

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Intl.
- Decided: Dec 11, 1998 after 249 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 K945620 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971710: Ultracon Ultrafiltrator, Quantic Biomedical, Inc. (1998) Summary page 1.

## Indications for use
The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

Source page: https://510kreport.com/device/K981253
Methodology: https://510kreport.com/methodology