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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 / July 2026 / K253814

510(k) cleared

Raney Clips Kit

Beijing Honghugaoxiang Science and Technology Development CO · Jul 21, 2026 · K253814

FDA cleared the Raney Clips Kit from Beijing Honghugaoxiang Science and Technology Development CO on Jul 21, 2026 under K253814, a traditional 510(k). The device falls under product code HBO, Clip, Scalp, regulated at 21 CFR 882.4150 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 28, 2025. The decision came 235 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 Beijing Honghugaoxiang Science and Technology Development CO in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253814?

K253814 is the FDA 510(k) for Raney Clips Kit, submitted by Beijing Honghugaoxiang Science and Technology Development CO. FDA's decision date was Jul 21, 2026, under product code HBO (Clip, Scalp).

Who makes the Raney Clips Kit?

Beijing Honghugaoxiang Science and Technology Development CO, based in Beijing, is the applicant of record for K253814.

How long did the K253814 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Jul 21, 2026, 235 days later.

← All decisions in July 2026