iLet® Dosing Decision Software
FDA 510(k) clearance K232224 · decided 2023-09-22
Clearance details
- K-number
- K232224
- Device name
- iLet® Dosing Decision Software
- Applicant
- Beta Bionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-27
- Decision date
- 2023-09-22
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- QJI
- Device class
- 2
- Regulation number
- 862.1356
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Concord, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software recall (Z-1809-2026) | Beta Bionics, Inc. | 2026-04-10 |