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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 / February 2026 / K251742

510(k) cleared

VELO Respiratory Test

Lex Diagnostics Limited · Feb 13, 2026 · K251742

FDA cleared the VELO Respiratory Test from Lex Diagnostics Limited on Feb 13, 2026 under K251742, a dual track 510(k). The device falls under product code QOF, Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, regulated at 21 CFR 866.3981 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 6, 2025. The decision came 252 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 Lex Diagnostics Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251742?

K251742 is the FDA 510(k) for VELO Respiratory Test, submitted by Lex Diagnostics Limited. FDA's decision date was Feb 13, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the VELO Respiratory Test?

Lex Diagnostics Limited, based in Melbourn, is the applicant of record for K251742.

How long did the K251742 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Feb 13, 2026, 252 days later.

← All decisions in February 2026