# K952621: EML105 Electrolyte Metabolite Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Oct 17, 1995 after 131 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 1 cites it directly.
0 of 47 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
- K962334: EML105 Electrolyte Metabolite Analyzer (1996), 45 descendants of its own
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System (1998), 44 descendants of its own
- K992859: ABL700 Series Analyzer with Autocheck Module (2000), 31 descendants of its own
- K041874: ABL800 Flex (2004), 29 descendants of its own
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own

Source page: https://510kreport.com/device/K952621
Methodology: https://510kreport.com/methodology