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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 / K260050

510(k) cleared

WRAP System

Huneo, LLC · Jul 15, 2026 · K260050

FDA cleared the WRAP System from Huneo, LLC on Jul 15, 2026 under K260050, a traditional 510(k). The device falls under product code MNR, Ventilatory Effort Recorder, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 7, 2026. The decision came 189 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 Huneo, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260050?

K260050 is the FDA 510(k) for WRAP System, submitted by Huneo, LLC. FDA's decision date was Jul 15, 2026, under product code MNR (Ventilatory Effort Recorder).

Who makes the WRAP System?

Huneo, LLC, based in Willoughby Hills, OH, is the applicant of record for K260050.

How long did the K260050 review take?

FDA received the submission on Jan 7, 2026 and issued its decision on Jul 15, 2026, 189 days later.

← All decisions in July 2026