FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iLet® Dosing Decision Software
K Number: K220916
·
Decision May 19, 2023
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
19
Applicant Total
6
Review Days
415
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Basic Information
- Device Name
- iLet® Dosing Decision Software
- K Number
- K220916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1356
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beta Bionics, Inc.
- Date Received
- March 30, 2022
- Decision Date
- May 19, 2023
- Product Code
- QJI
- 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 |
|---|---|---|---|
| QJI | Interoperable Automated Glycemic Controller | 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 |
| 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 |
| K223846 | iLet® ACE Pump | May 19, 2023 | Substantially Equivalent |