Cleared Traditional

K112734 - APLAN A.V. FISTULA NEEDLE SET

K112734 is an FDA 510(k) clearance for APLAN A.V. FISTULA NEEDLE SET, manufactured by Aplan Well Enterprise Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K112734 · Aplan Well Enterprise Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K112734

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 131d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K112734.
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
K131950 · Summit International Medical Technologies, Inc. · Jan 2015
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
K142564 · JMS North America Corporation · Dec 2014
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
K134019 · Nxstage Medical, Inc. · Sep 2014
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
K112178 · JMS North America Corporation · Oct 2011
WINGEATER V2
K111948 · JMS North America Corporation · Oct 2011
SYSLOC MINI V3
K110157 · JMS North America Corporation · Feb 2011