510(k) K250555
K250555 is an FDA 510(k) premarket notification submitted by Biocorp Production for the device "MallyaD injection pen adapter (MallyaD)". The FDA issued a decision of Substantially Equivalent on March 27, 2025. The device falls under product code QOG (Injection Data Capture Device), a Class II device regulated under 21 CFR 880.5860. Biocorp Production has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2025
- Date Received
- February 25, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injection Data Capture Device
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
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.