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510(k) K171450

Glooko Mobile Insulin Dosing System by Glooko, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2018
Date Received
May 17, 2017
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 Glooko, Inc.

  • K260910 — EndoTool IV Cloud 1.0 (May 1, 2026)
  • K132272 — GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (October 17, 2013)
  • K130886 — GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION (April 25, 2013)
  • K122142 — GLOOKO LOGBOOK CHARTS (December 21, 2012)

Other clearances for product code NDC

  • K254102 — Glucommander (May 27, 2026)
  • K260910 — EndoTool IV Cloud 1.0 (May 1, 2026)
  • K253512 — MiniMed Go App (January 8, 2026)
  • 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)
  • K230813 — BlueStar and BlueStar Rx (July 28, 2023)