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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 / December 2025 / K250805

510(k) cleared

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

Devilbiss Healthcare, LLC · Dec 9, 2025 · K250805

FDA cleared the DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) from Devilbiss Healthcare, LLC on Dec 9, 2025 under K250805, a traditional 510(k). The device falls under product code CAW, Generator, Oxygen, Portable, regulated at 21 CFR 868.5440 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Mar 17, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Devilbiss Healthcare, LLC has one other decision in the tracker over the last 12 months: K253549 (DeVilbiss 5 Liter Oxygen Concentrator (555)).

Questions & Answers

What did FDA clear under K250805?

K250805 is the FDA 510(k) for DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW), submitted by Devilbiss Healthcare, LLC. FDA's decision date was Dec 9, 2025, under product code CAW (Generator, Oxygen, Portable).

Who makes the DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)?

Devilbiss Healthcare, LLC, based in Somerset, PA, is the applicant of record for K250805.

How long did the K250805 review take?

FDA received the submission on Mar 17, 2025 and issued its decision on Dec 9, 2025, 267 days later.

← All decisions in December 2025

Sources