FDA cleared UpDoc on December 23 under K253281, an 85-day review from the September 29 receipt date. The Mountain View startup's software is a prescription SaMD for medication management in adults with type 2 diabetes. It sits under product code NDC, drug dose calculator, at 21 CFR 868.1890. The predicate is Hygieia's d-Nav System, K181916.
The 510(k) summary describes three parts: a provider portal, a patient app, and a cloud service. The cloud layer includes a Conversation Service the company calls the UpDoc Agent. Patients talk or type to the agent to log glucose readings, adherence, meals and symptoms. Insulin instructions come from a separate Clinical Service that applies parameters the prescriber sets. That split, chat for intake and rules for dosing, is how the device stays inside a Class II dose calculator code.
The summary states that no clinical testing was performed. The file relied on software verification under IEC 62304, cybersecurity testing against FDA's premarket guidance, and human factors validation. Founders Sharif Vakili and Ashwin Nayak ran a Stanford randomized trial of voice-based insulin titration, NCT05081011, before starting the company. UpDoc has not issued a release; the clearance appears in FDA's database.