510(k) clearance
twiist Loop Algorithm
- 510(k) number
- K262576
- Applicant
- Deka Research and Development Corp.
- Decision date
- Oct 15, 2026
- Date received
- Jul 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QJI
- Device type
- Interoperable Automated Glycemic Controller
- Device class
- Class II
- Regulation
- 21 CFR 862.1356
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Manchester, NH, US