# K040958: Prestige Models 24I and 400 and MGC Model 240

- Pathway: 510(k) (Traditional)
- Applicant: Tokyo Boeki Medical System, Ltd.
- Decided: Feb 15, 2005 after 308 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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 K851172 (1985). 1 ancestor in all.
2 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)
- K851172: Cobas Mira, Roche Diagnostic Systems, Inc. (1985) Summary page 2.

## Most influential descendants
- K120591: Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2 (2012), 0 descendants of its own
- K110520: Biolis 12I (2012), 0 descendants of its own

## Indications for use
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.

Source page: https://510kreport.com/device/K040958
Methodology: https://510kreport.com/methodology