# CGA: Glucose Oxidase, Glucose

- Device class: 2; regulation: 21 CFR 862.1345; FDA's rule: 510(k) required
- FDA decisions: 401
- 510(k) review time 2021–2025: median 307 days (middle half 205–738)
- Recalls: 71 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 4
- 2017: 2
- 2018: 2
- 2019: 2
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 4
- 2024: 2
- 2026: 1

## Most-cited predicates
- K002134: One Touch Ultra Blood Glucose Monitoring System (2000), cited by 10
- K993128: Healthbuddy with Device Connect [Glucose Meter] (1999), cited by 9
- K984261: Surestep Blood Glucose Monitoring System (1999), cited by 8
- K964630: Glucometer Elite Blood Glucose Meter (1997), cited by 6
- K984527: IN Touch Diabetes Management Software (1999), cited by 6
- K001387: I-Stat Portable Clinical Analyzer, Model 300 (2000), cited by 6
- K945887: Precision Q I D Blood Glucose Test Strips (1995), cited by 6
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (1999), cited by 6
- K051285: Glucolab Blood Glucose Monitoring System (2005), cited by 4
- K962295: Precision Qid Blood Glucose Test Strip (1996), cited by 4

Source page: https://510kreport.com/product-code/CGA
Data by year (CSV): https://510kreport.com/product-code/CGA.csv