Product code QOG— General Hospital
INSULCLOCK® v2.0 PRO
- Classification name
- Injection Data Capture Device
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Total cleared
- 7
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code QOG
FDA has cleared devices under product code QOG between 2022 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2022
Top applicants under product code QOG
Recent clearances under product code QOG
- K243901 — SmartPilot YpsoMate NS-A2.25
- K251500 — MallyaG Injection Pen Adapter (MallyaG)
- K250555 — MallyaD injection pen adapter (MallyaD)
- K241803 — INSULCLOCK® v2.0 PRO
- K231820 — SoloSmart Injection Pen Adapter (SoloSmart®)
- K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®)
- K212217 — Tempo Smart Button
Data sourced from openFDA. This site is unofficial and independent of the FDA.