Cleared Traditional

RENAX A.V. FISTULA NEEDLE SETS (K003123) - FDA 510(k) Clearance

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

K003123 · Sunder Biomedical Tech. Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2001
Decision
211d
Days
Class 2
Risk

K003123 is an FDA 510(k) clearance for the RENAX A.V. FISTULA NEEDLE SETS. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Sunder Biomedical Tech. Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on May 4, 2001 after a review of 211 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Sunder Biomedical Tech. Co., Ltd. devices

Submission Details

510(k) Number K003123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2000
Decision Date May 04, 2001
Days to Decision 211 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
81d slower than avg
Panel avg: 130d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - FIE Needle, Fistula

All 78
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K003123.
JMS CAVEO A.V. Fistula Needle Set
K251877 · JMS North America Corporation · Aug 2025
DORA Disposable A.V. Fistula Needle Sets
K213015 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Apr 2022
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505 · Dimesol, Inc. · May 2018
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983
A.V. FISTULA NEEDLE SET
K782021 · Cordis Corp. · Mar 1979