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510(k) K241803

INSULCLOCK® v2.0 PRO by Insulcloud S.L. — Product Code QOG

K241803 is an FDA 510(k) premarket notification submitted by Insulcloud S.L. for the device "INSULCLOCK® v2.0 PRO". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code QOG (Injection Data Capture Device), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2024
Date Received
June 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injection Data Capture Device
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.

Other clearances for product code QOG

  • K243901 — SmartPilot YpsoMate NS-A2.25 (August 28, 2025)
  • K251500 — MallyaG Injection Pen Adapter (MallyaG) (June 9, 2025)
  • K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
  • K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) (January 12, 2024)
  • K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®) (December 5, 2022)
  • K212217 — Tempo Smart Button (September 16, 2022)

FDA data resources