FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
twiist Automated Insulin Delivery (AID) System
K Number: K261672
·
Decision Jun 17, 2026
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
13
Review Days
27
Basic Information
- Device Name
- twiist Automated Insulin Delivery (AID) System
- K Number
- K261672
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deka Research and Development
- Date Received
- May 21, 2026
- Decision Date
- June 17, 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 |
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