K212217 is an FDA 510(k) clearance for the Tempo Smart Button. This device is classified as a Injection Data Capture Device (Class II - Special Controls, product code QOG).
Submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on September 16, 2022, 427 days after receiving the submission on July 16, 2021.
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 | K212217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2021 |
| Decision Date | September 16, 2022 |
| Days to Decision | 427 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. |