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 / September 2025 / K250050

510(k) cleared

miDiagnostics HSV-1&2 CSF Test

Midiagnostics NV · Sep 30, 2025 · K250050

FDA cleared the miDiagnostics HSV-1&2 CSF Test from Midiagnostics NV on Sep 30, 2025 under K250050, a traditional 510(k). The device falls under product code PGH, Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel, regulated at 21 CFR 866.3307 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 10, 2025. The decision came 263 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 Midiagnostics NV in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250050?

K250050 is the FDA 510(k) for miDiagnostics HSV-1&2 CSF Test, submitted by Midiagnostics NV. FDA's decision date was Sep 30, 2025, under product code PGH (Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel).

Who makes the miDiagnostics HSV-1&2 CSF Test?

Midiagnostics NV, based in Leuven, is the applicant of record for K250050.

How long did the K250050 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Sep 30, 2025, 263 days later.

← All decisions in September 2025