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The Tracker / October 2026 / K262576

510(k) cleared

twiist Loop Algorithm

Deka Research and Development Corp. · Oct 15, 2026 · K262576 · In the directory

FDA cleared the twiist Loop Algorithm from Deka Research and Development Corp. on Oct 15, 2026 under K262576, a traditional 510(k). The device falls under product code QJI, Interoperable Automated Glycemic Controller, regulated at 21 CFR 862.1356 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 27, 2026. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

Deka Research and Development Corp. has 2 other decisions in the tracker over the last 12 months: K261672 (twiist Automated Insulin Delivery (AID) System), K261530 (iiSure Infusion Set).

Questions & Answers

What did FDA clear under K262576?

K262576 is the FDA 510(k) for twiist Loop Algorithm, submitted by Deka Research and Development Corp.. FDA's decision date was Oct 15, 2026, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the twiist Loop Algorithm?

Deka Research and Development Corp., based in Manchester, NH, is the applicant of record for K262576. The company is listed in the MedDevice Startups directory.

How long did the K262576 review take?

FDA received the submission on Jul 27, 2026 and issued its decision on Oct 15, 2026, 80 days later.

← All decisions in October 2026

Sources

In the startup directory

Sequel Med Tech

Diabetes & Metabolic · Manchester, NH