K261672
- 510(k) number
- K261672
- Device name
- twiist Automated Insulin Delivery (AID) System
- Applicant
- Deka Research and Development NH · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2026-06-17
- Date received
- 2026-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261672.pdf
Official FDA record: K261672
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.