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The Tracker / September 2026 / K261896

510(k) cleared

iOS CamAPS FX

CamDiab · Sep 16, 2026 · K261896

FDA cleared the iOS CamAPS FX from CamDiab on Sep 16, 2026 under K261896, 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 Jun 8, 2026. The decision came 100 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for CamDiab in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261896?

K261896 is the FDA 510(k) for iOS CamAPS FX, submitted by CamDiab. FDA's decision date was Sep 16, 2026, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the iOS CamAPS FX?

CamDiab, based in London, is the applicant of record for K261896.

How long did the K261896 review take?

FDA received the submission on Jun 8, 2026 and issued its decision on Sep 16, 2026, 100 days later.

← All decisions in September 2026