# K971710: Ultracon Ultrafiltrator

- Pathway: 510(k) (Traditional)
- Applicant: Quantic Biomedical, Inc.
- Decided: Feb 27, 1998 after 295 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: 1 generation back to K945620 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945620: Altra Flux (TM) 140 Hemodialyzer, Althin Medical AB an Affiliate of Baxter Intl (1995) Summary page 1.
- (no number) Minifilter™ Hemofilter: named in the summary without a submission number
- (no number) Hemocor HPH™ 400 Hemoconcentrator: named in the summary without a submission number

## Most influential descendants
- K981253: Ultracon Ultrafiltrator (1998), 0 descendants of its own

## Indications for use
The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal of undesireable 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/K971710
Methodology: https://510kreport.com/methodology