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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 / January 2026 / DEN250005

510(k) cleared

Sana Device

Sana Health · Jan 16, 2026 · DEN250005

FDA cleared the Sana Device from Sana Health on Jan 16, 2026 under DEN250005, a direct 510(k). The device falls under product code QYN, Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use), regulated at 21 CFR 890.5775 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Mar 3, 2025. The decision came 319 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 Sana Health in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250005?

DEN250005 is the FDA 510(k) for Sana Device, submitted by Sana Health. FDA's decision date was Jan 16, 2026, under product code QYN (Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)).

Who makes the Sana Device?

Sana Health, based in Louisville, CO, is the applicant of record for DEN250005.

How long did the DEN250005 review take?

FDA received the submission on Mar 3, 2025 and issued its decision on Jan 16, 2026, 319 days later.

← All decisions in January 2026