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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 / November 2025 / K252687

510(k) cleared

Manual Wheelchair (HM305-Air1, HM305-Air2)

Suzhou Master Machinery Manufacturing Co.,Ltd · Nov 21, 2025 · K252687

FDA cleared the Manual Wheelchair (HM305-Air1, HM305-Air2) from Suzhou Master Machinery Manufacturing Co.,Ltd on Nov 21, 2025 under K252687, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Aug 26, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Suzhou Master Machinery Manufacturing Co.,Ltd has one other decision in the tracker over the last 12 months: K253870 (Electric Wheelchair (MP148)).

Questions & Answers

What did FDA clear under K252687?

K252687 is the FDA 510(k) for Manual Wheelchair (HM305-Air1, HM305-Air2), submitted by Suzhou Master Machinery Manufacturing Co.,Ltd. FDA's decision date was Nov 21, 2025, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (HM305-Air1, HM305-Air2)?

Suzhou Master Machinery Manufacturing Co.,Ltd, based in Kunshan, is the applicant of record for K252687.

How long did the K252687 review take?

FDA received the submission on Aug 26, 2025 and issued its decision on Nov 21, 2025, 87 days later.

← All decisions in November 2025

Sources