# K913806: Ysi Model 2300 Stat Plus

- Pathway: 510(k) (Traditional)
- Applicant: Ysis, Inc.
- Decided: Oct 2, 1991 after 37 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K980908: Lactate Pro System (1998), 2 descendants of its own
- K100602: Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips (2011), 1 descendant of its own
- K210933: YSI 2900C Biochemistry Analyzer (2024), 0 descendants of its own
- K112955: Nova Statstrip Lactate Hospital Meter System (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K913806
Methodology: https://510kreport.com/methodology