Cleared Traditional

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (K260394) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260394 · Hangzhou Jimushi Meditech Co., Ltd. · Gastroenterology & Urology device
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Jun 2026
Decision
138d
Days
Class 2
Risk

K260394 is an FDA 510(k) clearance for the Hydrophilic coated intermittent nalaton catheter for single use-ready to use .... Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Hangzhou Jimushi Meditech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 24, 2026 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou Jimushi Meditech Co., Ltd. devices

Submission Details

510(k) Number K260394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2026
Decision Date June 24, 2026
Days to Decision 138 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 130d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 43
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K260394.
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Liv Pre-lubricated Intermittent Catheter
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EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · HR Healthcare · Jan 2026
Ready to use Nelaton Catheter
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