Capability classes climb a ladder. First, U.S. regulators granted a De Novo path (September 2025) that created a Class II glucose range monitoring system type — originally labeled for prescription use only, for adults 22+ who are not on insulin.

On 24 September 2026, the company publicly announced FDA 510(k) clearance for over-the-counter use — expanding access without a prescription, for a needle-free wearable that tracks glucose, activity, and sleep. Treat that as a company-announced access expansion.

Honesty rule for authors and learners: the exact OTC 510(k) number was not published in Accessdata results retrieved the same day. Do not invent a K-number. Clearance news is not the same as every store already stocked, and OTC does not erase contraindications or the need for clinician judgment on medical action.