Cleared Traditional

K163025 - DORA Disposable A.V. Fistula Needle Sets

K163025 is an FDA 510(k) clearance for DORA Disposable A.V. Fistula Needle Sets, manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K163025 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
262d
Days
Class 2
Risk

K163025 is an FDA 510(k) clearance for the DORA Disposable A.V. Fistula Needle Sets. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 20, 2017 after a review of 262 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 Bain Medical Equipment (Guangzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K163025

510(k) Number K163025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date July 20, 2017
Days to Decision 262 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
132d slower than avg
Panel avg: 130d · This submission: 262d
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 41
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K163025.
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
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
K134019 · Nxstage Medical, Inc. · Sep 2014
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · Nipro Medical Corporation · Mar 2010
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K093985 · Nipro Medical Corp. · Jan 2010