K250555 is an FDA 510(k) clearance for the MallyaD injection pen adapter (MallyaD). This device is classified as a Injection Data Capture Device (Class II - Special Controls, product code QOG).
Submitted by Biocorp Production (Issoire, FR). The FDA issued a Cleared decision on March 27, 2025, 30 days after receiving the submission on February 25, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. 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..
| 510(k) Number | K250555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2025 |
| Decision Date | March 27, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QOG - Injection Data Capture Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| 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. |