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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 / October 2025 / K250860

510(k) cleared

BreatheBand® (Model 1000)

Exemplar Medical, LLC · Oct 2, 2025 · K250860

FDA cleared the BreatheBand® (Model 1000) from Exemplar Medical, LLC on Oct 2, 2025 under K250860, a traditional 510(k). The device falls under product code BYI, Percussor, Powered-Electric, regulated at 21 CFR 868.5665 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Mar 21, 2025. The decision came 195 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 Exemplar Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250860?

K250860 is the FDA 510(k) for BreatheBand® (Model 1000), submitted by Exemplar Medical, LLC. FDA's decision date was Oct 2, 2025, under product code BYI (Percussor, Powered-Electric).

Who makes the BreatheBand® (Model 1000)?

Exemplar Medical, LLC, based in Kansas City, MO, is the applicant of record for K250860.

How long did the K250860 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Oct 2, 2025, 195 days later.

← All decisions in October 2025