K222239 is an FDA 510(k) clearance for the SmartBolus Calculator. This device is classified as a Continuous Glucose Monitor Informed Insulin Dose Calculator (Class II - Special Controls, product code QRX).
Submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on August 19, 2022, 24 days after receiving the submission on July 26, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1358. A Continuous Glucose Monitor (cgm)-informed Insulin Dose Calculator Is A Software Device That Calculates Suggested Insulin Doses Based On Cgm Values And/or Other Relevant Information..
| 510(k) Number | K222239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2022 |
| Decision Date | August 19, 2022 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QRX — Continuous Glucose Monitor Informed Insulin Dose Calculator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1358 |
| Definition | A Continuous Glucose Monitor (cgm)-informed Insulin Dose Calculator Is A Software Device That Calculates Suggested Insulin Doses Based On Cgm Values And/or Other Relevant Information. |