Cleared Traditional

K260686 - Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter

K260686 is an FDA 510(k) clearance for Zylox PanFlex Percutaneous Transluminal..., manufactured by Zylox Medtech Co., Ltd.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K260686 · Zylox Medtech Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
233d
Days
Class 2
Risk

K260686 is an FDA 510(k) clearance for the Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Zylox Medtech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 22, 2026 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260686

510(k) Number K260686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2026
Decision Date October 22, 2026
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNO Device Classification - Class 2, Special Controls

Product Code PNO Catheter, Percutaneous, Cutting/scoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PNO Catheter, Percutaneous, Cutting/scoring

All 46
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K260686.
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K260686 · Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
Download PDF FDA Summary Zylox Medtech Co., Lt…