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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 / September 2025 / K250609

510(k) cleared

Sober Self-Test

Sober Ip, LLC · Sep 15, 2025 · K250609

FDA cleared the Sober Self-Test from Sober Ip, LLC on Sep 15, 2025 under K250609, a traditional 510(k). The device falls under product code DIC, Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, regulated at 21 CFR 862.3040 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Feb 28, 2025. The decision came 199 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 Sober Ip, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250609?

K250609 is the FDA 510(k) for Sober Self-Test, submitted by Sober Ip, LLC. FDA's decision date was Sep 15, 2025, under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method).

Who makes the Sober Self-Test?

Sober Ip, LLC, based in Southfield, MI, is the applicant of record for K250609.

How long did the K250609 review take?

FDA received the submission on Feb 28, 2025 and issued its decision on Sep 15, 2025, 199 days later.

← All decisions in September 2025