# K891480: Ysi Model 2300 Stat Glucose and L-Lactate Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Yellow Springs Instrument Co., Inc.
- Decided: May 22, 1989 after 66 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.
3 later devices descend from it; 3 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
- K203549: Nova Primary Glucose Analyzer System (2022), 0 descendants of its own
- K013938: Irma SL Blood Analysis System Lactate Cartridge (2002), 0 descendants of its own
- K011586: Irma SL Blood Analysis System GL Cartridge (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K891480
Methodology: https://510kreport.com/methodology