# CFR: Hexokinase, Glucose

- Device class: 2; regulation: 21 CFR 862.1345; FDA's rule: 510(k) required
- FDA decisions: 145
- 510(k) review time 2021–2025: median 164 days (middle half 126–203)
- Recalls: 20 (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)
- 2011: 3
- 2012: 4
- 2013: 1
- 2014: 1
- 2016: 2
- 2017: 1
- 2019: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) (2005), cited by 9
- K191899: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (2019), cited by 3
- K953847: Roche Reagent for Glucose (1996), cited by 3
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), cited by 2
- K944406: Olympus Glucose Reagent (1995), cited by 2
- K072018: BS-200 Chemistry Analyzer, Mode BS-200 (2008), cited by 2
- K060383: Glucose (2006), cited by 2
- K170316: Alinity C Glucose Reagent Kit, Alinity C System (2017), cited by 1
- K061048: Cobas Integra Glucose HK Gen. 3 Test System (2006), cited by 1
- K970664: Glucose Reagent (1997), cited by 1

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