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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 / K252458

510(k) cleared

Kyphoplasty Balloon Dilatation Catheters

Shanghai Lange Medtech Co., Ltd. · Nov 3, 2025 · K252458

FDA cleared the Kyphoplasty Balloon Dilatation Catheters from Shanghai Lange Medtech Co., Ltd. on Nov 3, 2025 under K252458, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 5, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shanghai Lange Medtech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252458?

K252458 is the FDA 510(k) for Kyphoplasty Balloon Dilatation Catheters, submitted by Shanghai Lange Medtech Co., Ltd.. FDA's decision date was Nov 3, 2025, under product code HRX (Arthroscope).

Who makes the Kyphoplasty Balloon Dilatation Catheters?

Shanghai Lange Medtech Co., Ltd., based in Shanghai, is the applicant of record for K252458.

How long did the K252458 review take?

FDA received the submission on Aug 5, 2025 and issued its decision on Nov 3, 2025, 90 days later.

← All decisions in November 2025