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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 / K250976

510(k) cleared

Airbile-100

Poskom Co., Ltd. · Dec 19, 2025 · K250976

FDA cleared the Airbile-100 from Poskom Co., Ltd. on Dec 19, 2025 under K250976, a traditional 510(k). The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 31, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Poskom Co., Ltd. has one other decision in the tracker over the last 12 months: K253244 (AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)).

Questions & Answers

What did FDA clear under K250976?

K250976 is the FDA 510(k) for Airbile-100, submitted by Poskom Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code IZL (System, X-Ray, Mobile).

Who makes the Airbile-100?

Poskom Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K250976.

How long did the K250976 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Dec 19, 2025, 263 days later.

← All decisions in December 2025

Sources