FDA Product Code QOG: Injection Data Capture Device
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.
Leading manufacturers include Biocorp Production, Eli Lilly and Company and Insulcloud S.L..
7
Total
7
Cleared
156d
Avg days
2022
Since
Declining activity -
3 submissions in the last 2 years
vs 4 in the prior period
Review times improving: avg
102d
recently vs 196d historically
FDA 510(k) Cleared Injection Data Capture Device Devices (Product Code QOG)
7 devices
Cleared
Aug 28, 2025
SmartPilot YpsoMate NS-A2.25
Ypsomed AG
General Hospital
252d
Cleared
Jun 09, 2025
MallyaG Injection Pen Adapter (MallyaG)
Biocorp Production
General Hospital
25d
Cleared
Mar 27, 2025
MallyaD injection pen adapter (MallyaD)
Biocorp Production
General Hospital
30d
Cleared
Aug 22, 2024
INSULCLOCK® v2.0 PRO
Insulcloud S.L.
General Hospital
62d
Cleared
Jan 12, 2024
SoloSmart Injection Pen Adapter (SoloSmart®)
Biocorp Production
General Hospital
205d
Cleared
Dec 05, 2022
Mallya Injection Pen Adapter (Mallya® for Solostar®)
Biocorp Production
General Hospital
90d
Cleared
Sep 16, 2022
Tempo Smart Button
Eli Lilly and Company
General Hospital
427d
About Product Code QOG - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QOG since 2022, with 7 receiving FDA clearance (average review time: 156 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - QOG Product Code
Recent submissions under QOG have taken an average of 102 days to reach a decision - down from 196 days historically, suggesting improved FDA processing for this classification.
QOG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →