twiist Loop Algorithm
by Deka Research and Development
510(k) K262576
twiist Loop Algorithm is a Class II device made by Deka Research and Development, cleared under FDA 510(k) K262576 on 15 Oct 2026, active as of 1 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK262576 | Date15 Oct 2026 | StatusActive |
Official records
- FDA 510(k) database K262576
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QJI
- FDA applicant
- Deka Research and Development Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1356
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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