twiist Loop Algorithm— 510(k) K262576

Name: FDA 510(k) clearance K262576
Creator: U.S. Food and Drug Administration
Published: 2026-10-15

Substantially Equivalent

Deka Research and Development Corp.

FDA 510(k) clearance K262576 for twiist Loop Algorithm, Substantially Equivalent on 2026-10-15. Applicant: Deka Research and Development Corp.. Device class: 2.

Clearance details

Applicant: Deka Research and Development Corp.
Product code: Product code QJI
Device class: Class 2
Regulation: 21 CFR 862.1356
Advisory panel: Clinical Chemistry
Date received: 2026-07-27
Decision date: 2026-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJI

view all

K261896 — iOS CamAPS FX2026-09-16
K262763 — iLet Dosing Decision Software2026-09-11
K261962 — SmartGuard Technology; Predictive Low Glucose Technology2026-07-09
K261461 — Omnipod 6 algorithm2026-06-29
K260429 — Control-IQ+ technology2026-04-24

More clearances from Deka Research and Development Corp.

view all

K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection2025-01-16

Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.