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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5860
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K243901Ypsomed AG · 510k2025-08-28
K251500Biocorp Production · 510k2025-06-09
K250555Biocorp Production · 510k2025-03-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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