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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 / K260382

510(k) cleared

MONARCH Platform (MON-000008)

Auris Health, Inc. · Jul 25, 2026 · K260382

FDA cleared the MONARCH Platform (MON-000008) from Auris Health, Inc. on Jul 25, 2026 under K260382, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Feb 5, 2026. The decision came 170 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Auris Health, Inc. has one other decision in the tracker over the last 12 months: DEN250068 (OTTAVA Robotic Surgical System).

Questions & Answers

What did FDA clear under K260382?

K260382 is the FDA 510(k) for MONARCH Platform (MON-000008), submitted by Auris Health, Inc.. FDA's decision date was Jul 25, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the MONARCH Platform (MON-000008)?

Auris Health, Inc., based in Santa Clara, CA, is the applicant of record for K260382.

How long did the K260382 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Jul 25, 2026, 170 days later.

← All decisions in July 2026

Sources