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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 / July 2026 / K260021

510(k) cleared

cobas® BV/CV

Roche Molecular Systems, Inc. · Jul 16, 2026 · K260021

FDA cleared the cobas® BV/CV from Roche Molecular Systems, Inc. on Jul 16, 2026 under K260021, a traditional 510(k). The device falls under product code PQA, Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, regulated at 21 CFR 866.3975 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 5, 2026. The decision came 192 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roche Molecular Systems, Inc. has 6 other decisions in the tracker over the last 12 months: K260917 (cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems), K253756 (cobas liat CT/NG nucleic acid test), K253759 (cobas liat CT/NG/MG nucleic acid test), K243753 (cobas liat Bordetella panel nucleic acid test).

Questions & Answers

What did FDA clear under K260021?

K260021 is the FDA 510(k) for cobas® BV/CV, submitted by Roche Molecular Systems, Inc.. FDA's decision date was Jul 16, 2026, under product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System).

Who makes the cobas® BV/CV?

Roche Molecular Systems, Inc., based in Pleasanton, CA, is the applicant of record for K260021.

How long did the K260021 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Jul 16, 2026, 192 days later.

← All decisions in July 2026