# K854298: IRON

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 12, 1985 after 18 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K981652: CHOL (1998), 1 descendant of its own
- K203597: Cholesterol2 (2022), 0 descendants of its own
- K981581: IRON (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K854298
Methodology: https://510kreport.com/methodology