# K960120: Stat Profile Ultra F,G,H,I,J, and K Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Mar 11, 1996 after 60 days
- Product code: JFP (Electrode, Ion Specific, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990092: Avl Omni Modular Analyzer (1999), 7 descendants of its own
- K013373: Omni C Analyzer (2001), 2 descendants of its own
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own
- K131126: Opti Cca-TS2 (2013), 1 descendant of its own
- K032311: Roche Diagnostics Omni S Analyzer (2003), 1 descendant of its own

Source page: https://510kreport.com/device/K960120
Methodology: https://510kreport.com/methodology