twiist Automated Insulin Delivery (AID) System— 510(k) K261672
Substantially EquivalentDeka Research and Development
FDA 510(k) clearance K261672 for twiist Automated Insulin Delivery (AID) System, Substantially Equivalent on 2026-06-17. Applicant: Deka Research and Development. Device class: 2.
Summary
The twiist Automated Insulin Delivery (AID) System from Deka Research and Development is filed under QFG, alternate controller enabled insulin infusion pumps. The record doesn't list the system's components.
Class II, 21 CFR 880.5730. Clinical Chemistry is both the classification panel and the review panel, and the submission was a Special 510(k).
Deka filed from Manchester, New Hampshire. The decision came 27 calendar days after receipt (May 21 to June 17, 2026).
Clearance details
- Applicant
- Deka Research and Development
- Product code
- Product code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Manchester, NH, US
Recent devices under product code QFG
view allMore clearances from Deka Research and Development
view allAdverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.