Cleared Traditional

K151745 - FULL CARE Disposable PVC Nelaton Catheter

K151745 is an FDA 510(k) clearance for FULL CARE Disposable PVC Nelaton Catheter, manufactured by Shaoxing Fuqing Health Products Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K151745 · Shaoxing Fuqing Health Products Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
248d
Days
Class 2
Risk

K151745 is an FDA 510(k) clearance for the FULL CARE Disposable PVC Nelaton Catheter. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Shaoxing Fuqing Health Products Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on March 3, 2016 after a review of 248 days - an extended review cycle.

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 Shaoxing Fuqing Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K151745

510(k) Number K151745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2015
Decision Date March 03, 2016
Days to Decision 248 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
118d slower than avg
Panel avg: 130d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

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 50
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