# NBW: System, Test, Blood Glucose, Over The Counter

- Device class: 2; regulation: 21 CFR 862.1345; FDA's rule: 510(k) required
- FDA decisions: 513
- 510(k) review time 2021–2025: median 267 days (middle half 157–496)
- Recalls: 95 (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)
- 2017: 25
- 2018: 19
- 2019: 10
- 2020: 7
- 2021: 7
- 2022: 12
- 2023: 5
- 2024: 7
- 2025: 2
- 2026: 5

## Most-cited predicates
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems (2003), cited by 15
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color) (2009), cited by 12
- K090187: Fora G30 Blood Glucose Monitoring System, Model TD-4241 (2009), cited by 8
- K021513: Accu-Chek Advantage Module (2002), cited by 8
- K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 (2006), cited by 7
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos (2010), cited by 7
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005 (2003), cited by 6
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System (2006), cited by 6
- K042678: Rightest Blood Glucose Monitoring System (2005), cited by 6
- K012014: Modification to Blood Glucose Monitoring System (2001), cited by 5

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