WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / June 2026 / K260270

510(k) cleared

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

FindAir Sp. z o.o. · Jun 2, 2026 · K260270

FDA cleared the FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) from FindAir Sp. z o.o. on Jun 2, 2026 under K260270, a traditional 510(k). The device falls under product code CAF, Nebulizer (Direct Patient Interface), regulated at 21 CFR 868.5630 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 28, 2026. The decision came 125 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 FindAir Sp. z o.o. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260270?

K260270 is the FDA 510(k) for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001), submitted by FindAir Sp. z o.o.. FDA's decision date was Jun 2, 2026, under product code CAF (Nebulizer (Direct Patient Interface)).

Who makes the FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?

FindAir Sp. z o.o., based in Kraków, is the applicant of record for K260270.

How long did the K260270 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Jun 2, 2026, 125 days later.

← All decisions in June 2026