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510(k) K230813

BlueStar and BlueStar Rx by Welldoc, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2023
Date Received
March 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

Other clearances by Welldoc, Inc.

  • K222888 — BlueStar CGM insulin dose calculator (August 11, 2023)
  • K203434 — BlueStar Rx (September 8, 2021)
  • K193654 — BlueStar Rx (April 7, 2020)
  • K190013 — WellDoc BlueStar (November 4, 2019)
  • K162532 — WellDoc BlueStar, WellDoc BlueStar Rx (January 12, 2017)
  • K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (November 22, 2016)
  • K141273 — WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE (July 8, 2014)
  • K120314 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (February 24, 2012)
  • K112370 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (October 14, 2011)
  • K100066 — DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 (July 15, 2010)

Other clearances for product code NDC

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  • K253281 — UpDoc (December 23, 2025)
  • K252104 — T1D1 (August 20, 2025)
  • K241088 — EndoTool IV (3.1) (December 11, 2024)
  • K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (November 12, 2024)
  • K242066 — iSage Rx (August 21, 2024)
  • K232451 — Insulia Bolus Companion (December 12, 2023)
  • K221924 — Digital Routines (March 15, 2023)
  • K211160 — EndoTool SubQ 2.1 (October 28, 2021)
  • K203434 — BlueStar Rx (September 8, 2021)