Cleared Traditional

APLAN A.V. FISTULA NEEDLE SET (K112734) - FDA 510(k) Clearance

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

K112734 · Aplan Well Enterprise Co., Ltd. · Gastroenterology & Urology device
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Apr 2012
Decision
217d
Days
Class 2
Risk

K112734 is an FDA 510(k) clearance for the APLAN A.V. FISTULA NEEDLE SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Aplan Well Enterprise Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on April 24, 2012 after a review of 217 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 Aplan Well Enterprise Co., Ltd. devices

Submission Details

510(k) Number K112734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date April 24, 2012
Days to Decision 217 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
87d slower than avg
Panel avg: 130d · This submission: 217d
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 K112734.
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