Cleared Special

K112178 - JMS APHERESIS NEEDLE SET WINGEATER(R) V2

K112178 is an FDA 510(k) clearance for JMS APHERESIS NEEDLE SET WINGEATER V2, 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 91-day FDA review.

K112178 · JMS North America Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
91d
Days
Class 2
Risk

K112178 is an FDA 510(k) clearance for the JMS APHERESIS NEEDLE SET WINGEATER(R) V2. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by JMS North America Corporation (Crofton, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K112178

510(k) Number K112178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2011
Decision Date October 27, 2011
Days to Decision 91 days
Submission Type Special
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
40d faster than avg
Panel avg: 131d · This submission: 91d
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 69
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K112178.
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
APLAN A.V. FISTULA NEEDLE SET
K112734 · Aplan Well Enterprise Co., Ltd. · Apr 2012
WINGEATER V2
K111948 · JMS North America Corporation · Oct 2011
SYSLOC MINI V3
K110157 · JMS North America Corporation · Feb 2011
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · Nipro Medical Corporation · Mar 2010