FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iLet ACE Pump
K Number: K253976
·
Decision Apr 30, 2026
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
6
Review Days
139
Basic Information
- Device Name
- iLet ACE Pump
- K Number
- K253976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beta Bionics, Inc.
- Date Received
- December 12, 2025
- Decision Date
- April 30, 2026
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QFG), ordered by most recent decision date.
twiist Automated Insulin Delivery (AID) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MiniMed Flex pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tandem Mobi insulin pump with interoperable technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iLet ACE Pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
t:slim X2 insulin pump with interoperable technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Beta Bionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252770 | iLet ACE Pump | Sep 29, 2025 | 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 |