Cleared Special

K151017 - JMS Harmony A.V. Fistula Needle Set

K151017 is an FDA 510(k) clearance for JMS Harmony A.V. Fistula Needle Set, manufactured by JMS North America Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Special 510(k) pathway after a 27-day FDA review.

K151017 · JMS North America Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
27d
Days
Class 2
Risk

K151017 is an FDA 510(k) clearance for the JMS Harmony A.V. Fistula Needle Set. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by JMS North America Corporation (Hayward, US). The FDA issued a Cleared decision on May 13, 2015 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all JMS North America Corporation devices

FDA 510(k) Submission Details - K151017

510(k) Number K151017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2015
Decision Date May 13, 2015
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K151017.
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