K241803 is an FDA 510(k) clearance for the INSULCLOCK® v2.0 PRO. This device is classified as a Injection Data Capture Device (Class II - Special Controls, product code QOG).
Submitted by Insulcloud S.L. (Bibao, ES). The FDA issued a Cleared decision on August 22, 2024, 62 days after receiving the submission on June 21, 2024.
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 | K241803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2024 |
| Decision Date | August 22, 2024 |
| Days to Decision | 62 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. |