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510(k) K231820

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

K231820 is an FDA 510(k) premarket notification submitted by Biocorp Production for the device "SoloSmart Injection Pen Adapter (SoloSmart®)". The FDA issued a decision of Substantially Equivalent on January 12, 2024. The device falls under product code QOG (Injection Data Capture Device), a Class II device regulated under 21 CFR 880.5860. Biocorp Production has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2024
Date Received
June 21, 2023
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

  • K251500 — MallyaG Injection Pen Adapter (MallyaG) (June 9, 2025)
  • K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
  • 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)
  • K251500 — MallyaG Injection Pen Adapter (MallyaG) (June 9, 2025)
  • K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
  • K241803 — INSULCLOCK® v2.0 PRO (August 22, 2024)
  • K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®) (December 5, 2022)
  • K212217 — Tempo Smart Button (September 16, 2022)

FDA data resources