# NDC: Calculator, Drug Dose

- Device class: 2; regulation: 21 CFR 868.1890; FDA's rule: 510(k) required
- FDA decisions: 56
- 510(k) review time 2021–2025: median 126 days (middle half 73–247)
- Recalls: 9 (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)
- 2016: 2
- 2017: 8
- 2018: 3
- 2019: 1
- 2020: 5
- 2021: 3
- 2023: 3
- 2024: 3
- 2025: 2
- 2026: 4

## Most-cited predicates
- K113853: G+ System (2012), cited by 5
- K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite (2001), cited by 5
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), cited by 3
- K082512: Intelligent Dosing System for Insulin-MY Insulin Doser (2008), cited by 3
- K053137: Endotool Drug Dose Calculator (2006), cited by 3
- K132547: Endo Tool Glucose Management System (Egms) (2014), cited by 3
- K190487: InPen Dose Calculator (2020), cited by 3
- K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (2024), cited by 3
- K071713: Clarian Glucose Stabilizer Insulin Dosing Calculator (2007), cited by 2
- K161433: Insulia Diabetes Management Companion (2016), cited by 2

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