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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 / May 2026 / K253569

510(k) cleared

Atmo Gas Capsule System

Atmo Biosciences, Ltd. · May 22, 2026 · K253569

FDA cleared the Atmo Gas Capsule System from Atmo Biosciences, Ltd. on May 22, 2026 under K253569, a traditional 510(k). The device falls under product code NYV, Gastrointestinal Motility System, Capsule, regulated at 21 CFR 876.1725 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 17, 2025. The decision came 186 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 Atmo Biosciences, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253569?

K253569 is the FDA 510(k) for Atmo Gas Capsule System, submitted by Atmo Biosciences, Ltd.. FDA's decision date was May 22, 2026, under product code NYV (Gastrointestinal Motility System, Capsule).

Who makes the Atmo Gas Capsule System?

Atmo Biosciences, Ltd., based in Box Hill, is the applicant of record for K253569.

How long did the K253569 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on May 22, 2026, 186 days later.

← All decisions in May 2026