K222689 is an FDA 510(k) clearance for the Mallya Injection Pen Adapter (Mallya® for Solostar®). 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 December 5, 2022, 90 days after receiving the submission on September 6, 2022.
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 | K222689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2022 |
| Decision Date | December 05, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| 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. |