SoloSmart Injection Pen Adapter (SoloSmart®)
FDA 510(k) K231820 · Biocorp Production
510(k) numberK231820
Submission
- Device name
- SoloSmart Injection Pen Adapter (SoloSmart®)
- Applicant
- Biocorp Production
Issoire, FR - Received
- June 21, 2023
- Decision date
- January 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K241803 | INSULCLOCK® v2.0 PROQOG · Traditional | Insulcloud S.L. | 08/22/2024SE |
| 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 |
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Questions and answers
When was SoloSmart Injection Pen Adapter (SoloSmart®) cleared by the FDA?
SoloSmart Injection Pen Adapter (SoloSmart®) (K231820) received a 510(k) decision of Substantially Equivalent on January 12, 2024, 205 days after the submission was received.
What is the product code of K231820?
The FDA product code is QOG – Injection Data Capture Device, a Class II (moderate risk) device regulated under 21 CFR 880.5860.