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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 / October 2025 / K251595

510(k) cleared

COVID-19 Detect Rapid Self -Test

InBios International, Inc. · Oct 12, 2025 · K251595

FDA cleared the COVID-19 Detect Rapid Self -Test from InBios International, Inc. on Oct 12, 2025 under K251595, a traditional 510(k). The device falls under product code QYT, Over-The-Counter Covid-19 Antigen Test, regulated at 21 CFR 866.3984 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on May 27, 2025. The decision came 138 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 InBios International, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251595?

K251595 is the FDA 510(k) for COVID-19 Detect Rapid Self -Test, submitted by InBios International, Inc.. FDA's decision date was Oct 12, 2025, under product code QYT (Over-The-Counter Covid-19 Antigen Test).

Who makes the COVID-19 Detect Rapid Self -Test?

InBios International, Inc., based in Seattle, WA, is the applicant of record for K251595.

How long did the K251595 review take?

FDA received the submission on May 27, 2025 and issued its decision on Oct 12, 2025, 138 days later.

← All decisions in October 2025