FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iLet ACE Pump
K Number: K252770
·
Decision Sep 29, 2025
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
6
Review Days
27
Basic Information
- Device Name
- iLet ACE Pump
- K Number
- K252770
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beta Bionics, Inc.
- Date Received
- September 2, 2025
- Decision Date
- September 29, 2025
- Product Code
- QFG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | FDA class 2 | Clinical Chemistry |
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Other Clearances by Beta Bionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253976 | iLet ACE Pump | Apr 30, 2026 | Substantially Equivalent |
| K232224 | iLet® Dosing Decision Software | Sep 22, 2023 | Substantially Equivalent |
| K231485 | iLet® ACE Pump | Jun 21, 2023 | Substantially Equivalent |
| K220916 | iLet® Dosing Decision Software | May 19, 2023 | Substantially Equivalent |
| K223846 | iLet® ACE Pump | May 19, 2023 | Substantially Equivalent |