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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 / K252076

510(k) cleared

Kneevoice Cartilage Evaluation System (750-3600-001)

Kneevoice, Inc. · Feb 6, 2026 · K252076

FDA cleared the Kneevoice Cartilage Evaluation System (750-3600-001) from Kneevoice, Inc. on Feb 6, 2026 under K252076, a traditional 510(k). The device falls under product code DQD, Stethoscope, Electronic, regulated at 21 CFR 870.1875 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 2, 2025. The decision came 219 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 Kneevoice, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252076?

K252076 is the FDA 510(k) for Kneevoice Cartilage Evaluation System (750-3600-001), submitted by Kneevoice, Inc.. FDA's decision date was Feb 6, 2026, under product code DQD (Stethoscope, Electronic).

Who makes the Kneevoice Cartilage Evaluation System (750-3600-001)?

Kneevoice, Inc., based in Santa Monica, CA, is the applicant of record for K252076.

How long did the K252076 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Feb 6, 2026, 219 days later.

← All decisions in February 2026