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510(k) K193654

BlueStar Rx by Welldoc, Inc. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2020
Date Received
December 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Welldoc, Inc.

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  • 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 MRZ

  • K230718 — UTC 3mL Medication Cartridge (June 15, 2023)
  • K220695 — Elite Biomedical Solutions Dose Request Cord (April 29, 2022)
  • K201634 — RG 3ml Medication Cartridge (March 26, 2021)
  • K191910 — SpaceStation MRI (March 12, 2020)
  • K190013 — WellDoc BlueStar (November 4, 2019)
  • K173531 — Lockbox for Perfusor Space PCA Infusion Pump (August 2, 2018)
  • K171346 — Sapphire Sets (August 25, 2017)
  • K162532 — WellDoc BlueStar, WellDoc BlueStar Rx (January 12, 2017)
  • K160492 — Hospira Sapphire Sets (December 6, 2016)
  • K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (November 22, 2016)