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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K253281

510(k) cleared

UpDoc

Updoc, Inc. · Dec 23, 2025 · K253281 · In the directory

FDA cleared the UpDoc from Updoc, Inc. on Dec 23, 2025 under K253281, a traditional 510(k). The device falls under product code NDC, Calculator, Drug Dose, regulated at 21 CFR 868.1890 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Updoc, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253281?

K253281 is the FDA 510(k) for UpDoc, submitted by Updoc, Inc.. FDA's decision date was Dec 23, 2025, under product code NDC (Calculator, Drug Dose).

Who makes the UpDoc?

Updoc, Inc., based in Mountain View, CA, is the applicant of record for K253281. The company is listed in the MedDevice Startups directory.

How long did the K253281 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 23, 2025, 85 days later.

← All decisions in December 2025

Sources

In the startup directory

UpDoc

Digital Health & SaMD · Mountain View, CA

UpDoc

OUR COVERAGE

Questions & Answers

What did FDA clear under K253281?

Who makes the UpDoc?

How long did the K253281 review take?