# Welldoc, Inc.

- Location (FDA's records): Columbia, MD
- FDA decisions: 11 (2010–2023): 11 510(k) clearances
- Product codes: MRZ (8), NDC (2), QRX (1)
- Predicates its devices cite: 10 (6 its own); citations of its devices by later devices: 10 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Insulet Corporation: 1 (https://510kreport.com/company/insulet)
- Glooko, Inc.: 1 (https://510kreport.com/company/glooko)

## Firms that cite its devices most
- Voluntis Sa.: 1 (https://510kreport.com/company/voluntis)
- Gnc Holdings, LLC: 1 (https://510kreport.com/company/gnc-holdings)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)
- Dexcom, Inc.: 1 (https://510kreport.com/company/dexcom)

## Its most-cited devices
- K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 (2010), cited by 3
- K193654: BlueStar Rx (2020), cited by 2
- K190013: WellDoc BlueStar (2019), cited by 1
- K162532: WellDoc BlueStar, WellDoc BlueStar Rx (2017), cited by 1
- K203434: BlueStar Rx (2021), cited by 1
- K141273: Welldoc Diabetesmanager System and Diabetesmanager- RX Syste (2014), cited by 1

## Recent decisions
- K222888: BlueStar CGM insulin dose calculator (Aug 11, 2023)
- K230813: BlueStar and BlueStar Rx (Jul 28, 2023)
- K203434: BlueStar Rx (Sep 8, 2021)
- K193654: BlueStar Rx (Apr 7, 2020)
- K190013: WellDoc BlueStar (Nov 4, 2019)
- K162532: WellDoc BlueStar, WellDoc BlueStar Rx (Jan 12, 2017)
- K162225: WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (Nov 22, 2016)
- K141273: Welldoc Diabetesmanager System and Diabetesmanager- RX Syste (Jul 8, 2014)

Source page: https://510kreport.com/company/welldoc