INSULCLOCK® v2.0 PRO
FDA 510(k) K241803 · Insulcloud S.L.
510(k) numberK241803
Submission
- Device name
- INSULCLOCK® v2.0 PRO
- Applicant
- Insulcloud S.L.
Bibao, ES - Received
- June 21, 2024
- Decision date
- August 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOG – Injection Data Capture Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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 510(k)s with product code QOG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25QOG · Traditional | Ypsomed AG | 08/28/2025SE |
| K251500 | MallyaG Injection Pen Adapter (MallyaG)QOG · Special | Biocorp Production | 06/09/2025SE |
| K250555 | MallyaD injection pen adapter (MallyaD)QOG · Special | Biocorp Production | 03/27/2025SE |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®)QOG · Special | Biocorp Production | 01/12/2024SE |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®)QOG · Traditional | Biocorp Production | 12/05/2022SE |
| K212217 | Tempo Smart ButtonQOG · Traditional | Eli Lilly and Company | 09/16/2022SE |
Questions and answers
When was INSULCLOCK® v2.0 PRO cleared by the FDA?
INSULCLOCK® v2.0 PRO (K241803) received a 510(k) decision of Substantially Equivalent on August 22, 2024, 62 days after the submission was received.
What is the product code of K241803?
The FDA product code is QOG – Injection Data Capture Device, a Class II (moderate risk) device regulated under 21 CFR 880.5860.