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510(k) K251500

MallyaG Injection Pen Adapter (MallyaG) by Biocorp Production — Product Code QOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2025
Date Received
May 15, 2025
Clearance Type
Special
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 by Biocorp Production

  • 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)

Other clearances for product code QOG

  • K243901 — SmartPilot YpsoMate NS-A2.25 (August 28, 2025)
  • K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
  • K241803 — INSULCLOCK® v2.0 PRO (August 22, 2024)
  • 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)