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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 / November 2025 / K251872

510(k) cleared

Biomoneta Avata Rx

Biomoneta Research Private Limited · Nov 14, 2025 · K251872

FDA cleared the Biomoneta Avata Rx from Biomoneta Research Private Limited on Nov 14, 2025 under K251872, a traditional 510(k). The device falls under product code FRF, Cleaner, Air, Medical Recirculating, regulated at 21 CFR 880.5045 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 18, 2025. The decision came 149 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 Biomoneta Research Private Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251872?

K251872 is the FDA 510(k) for Biomoneta Avata Rx, submitted by Biomoneta Research Private Limited. FDA's decision date was Nov 14, 2025, under product code FRF (Cleaner, Air, Medical Recirculating).

Who makes the Biomoneta Avata Rx?

Biomoneta Research Private Limited, based in Bengaluru, is the applicant of record for K251872.

How long did the K251872 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Nov 14, 2025, 149 days later.

← All decisions in November 2025