# LFR: Glucose Dehydrogenase, Glucose

- Device class: 2; regulation: 21 CFR 862.1345; FDA's rule: 510(k) required
- FDA decisions: 73
- Recalls: 45 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 2
- 2005: 3
- 2006: 1
- 2007: 1
- 2009: 1
- 2011: 6
- 2012: 13
- 2013: 3
- 2014: 3
- 2015: 1

## Most-cited predicates
- K043474: Accu-Chek Aviva System (2005), cited by 10
- K992684: Freestyle Blood Glucose Monitoring System (2000), cited by 8
- K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001 (2000), cited by 5
- K951887: Advantage Test Strips (1995), cited by 4
- K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System (2011), cited by 4
- K954833: Accu-Chek Advantage Test Strips (1996), cited by 3
- K982002: Accu-Chek Comfort Curve Test Strip (1998), cited by 3
- K980731: Accu-Chek Comfort Curve Test Strips (1998), cited by 3
- K031755: Accu-Chek Compact Test Strip (2003), cited by 3
- K994433: Connect Data Management System (2000), cited by 3

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