SmartBolus Calculator
FDA 510(k) clearance K231824 · decided 2023-10-18
Clearance details
- K-number
- K231824
- Device name
- SmartBolus Calculator
- Applicant
- Insulet Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-06-21
- Decision date
- 2023-10-18
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- QRX
- Device class
- 2
- Regulation number
- 862.1358
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dexcom Smart Basal (K252818) | Dexcom, Inc. | 2025-11-18 |
| BlueStar CGM insulin dose calculator (K222888) | Welldoc, Inc. | 2023-08-11 |
| SmartBolus Calculator (K222239) | Insulet Corporation | 2022-08-19 |
| Omnipod 5 SmartBolus Calculator (K203772) | Insulet Corporation | 2022-01-27 |
Recalls involving this device
No recalls on record reference this clearance.