iLet ACE Pump
FDA 510(k) clearance K252770 · decided 2025-09-29
Clearance details
- K-number
- K252770
- Device name
- iLet ACE Pump
- Applicant
- Beta Bionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-02
- Decision date
- 2025-09-29
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QFG
- Device class
- 2
- Regulation number
- 880.5730
- 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 Bionic Pancreas, REF: BB1001 recall (Z-2513-2026) | Beta Bionics, Inc. | 2026-06-18 |
| iLet Bionic Pancreas, REF: BB1001 recall (Z-1996-2026) | Beta Bionics, Inc. | 2026-04-29 |