Cleared Traditional

UpDoc

K253281 · Updoc, Inc. · Chemistry
Dec 2025
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K253281 is an FDA 510(k) clearance for the UpDoc, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Updoc, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 23, 2025, 85 days after receiving the submission on September 29, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K253281 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date December 23, 2025
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890