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The Tracker / September 2026 / K260416

510(k) cleared

ZYLOX Hippo PTA Balloon Dilatation Catheter

Zylox Medtech Co., Ltd. · Sep 21, 2026 · K260416

FDA cleared the ZYLOX Hippo PTA Balloon Dilatation Catheter from Zylox Medtech Co., Ltd. on Sep 21, 2026 under K260416, a traditional 510(k). The device falls under product code LIT, Catheter, Angioplasty, Peripheral, Transluminal, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 9, 2026. The decision came 224 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 Zylox Medtech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260416?

K260416 is the FDA 510(k) for ZYLOX Hippo PTA Balloon Dilatation Catheter, submitted by Zylox Medtech Co., Ltd.. FDA's decision date was Sep 21, 2026, under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal).

Who makes the ZYLOX Hippo PTA Balloon Dilatation Catheter?

Zylox Medtech Co., Ltd., based in Hangzhou, is the applicant of record for K260416.

How long did the K260416 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Sep 21, 2026, 224 days later.

← All decisions in September 2026