WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K251501

510(k) cleared

Visby Medical Men's Sexual Health Test

Visby Medical, Inc. · Oct 1, 2025 · K251501

FDA cleared the Visby Medical Men's Sexual Health Test from Visby Medical, Inc. on Oct 1, 2025 under K251501, a dual track 510(k). The device falls under product code QEP, Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, regulated at 21 CFR 866.3393 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on May 15, 2025. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Visby Medical, Inc. has one other decision in the tracker over the last 12 months: K253971 (Visby Medical Flu and COVID-19 Test).

Questions & Answers

What did FDA clear under K251501?

K251501 is the FDA 510(k) for Visby Medical Men's Sexual Health Test, submitted by Visby Medical, Inc.. FDA's decision date was Oct 1, 2025, under product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections).

Who makes the Visby Medical Men's Sexual Health Test?

Visby Medical, Inc., based in San Jose, CA, is the applicant of record for K251501.

How long did the K251501 review take?

FDA received the submission on May 15, 2025 and issued its decision on Oct 1, 2025, 139 days later.

← All decisions in October 2025

Sources