FIE · Class II · 21 CFR 876.5540

FDA Product Code FIE: Needle, Fistula

Leading manufacturers include Jms Co., Ltd., Sorensen Research and Medisystems Corp..

80
Total
80
Cleared
122d
Avg days
1977
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 179d recently vs 121d historically

FDA 510(k) Cleared Needle, Fistula Devices (Product Code FIE)

80 devices
1–24 of 80
Cleared Aug 06, 2026
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)
K253469
Mozarc Medical Us, LLC
Gastroenterology & Urology · 300d
Cleared Aug 15, 2025
JMS CAVEO A.V. Fistula Needle Set
K251877
JMS North America Corporation
Gastroenterology & Urology · 58d
Cleared Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
K213015
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology · 200d
Cleared May 17, 2018
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505
Dimesol, Inc.
Gastroenterology & Urology · 359d
Cleared Jul 20, 2017
DORA Disposable A.V. Fistula Needle Sets
K163025
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology · 262d
Cleared May 13, 2015
JMS Harmony A.V. Fistula Needle Set
K151017
JMS North America Corporation
Gastroenterology & Urology · 27d
Cleared Jan 16, 2015
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
K131950
Summit International Medical Technologies, Inc.
Gastroenterology & Urology · 568d
Cleared Dec 23, 2014
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
K142564
JMS North America Corporation
Gastroenterology & Urology · 103d
Cleared Sep 11, 2014
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
K134019
Nxstage Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Apr 24, 2012
APLAN A.V. FISTULA NEEDLE SET
K112734
Aplan Well Enterprise Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Oct 27, 2011
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
K112178
JMS North America Corporation
Gastroenterology & Urology · 91d
Cleared Oct 24, 2011
WINGEATER V2
K111948
JMS North America Corporation
Gastroenterology & Urology · 108d
Cleared Feb 11, 2011
SYSLOC MINI V3
K110157
JMS North America Corporation
Gastroenterology & Urology · 23d
Cleared Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520
Nipro Medical Corporation
Gastroenterology & Urology · 22d
Cleared Jan 22, 2010
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K093985
Nipro Medical Corp.
Gastroenterology & Urology · 29d
Cleared Feb 12, 2007
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
K062953
Medisystems Corp.
Gastroenterology & Urology · 136d
Cleared Feb 05, 2007
NIPRO BIOHOLE NEEDLE
K063368
Nipro Medical Corp.
Gastroenterology & Urology · 90d
Cleared Jan 12, 2007
NIPRO SAFETOUCH II GAMMA
K063721
Nipro Medical Corp.
Gastroenterology & Urology · 28d
Cleared Oct 27, 2006
SUPERCATH V
K052267
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 434d
Cleared Aug 04, 2005
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
K051814
Jms North America Corp.
Gastroenterology & Urology · 30d
Cleared Sep 06, 2001
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352
Jms Co., Ltd.
Gastroenterology & Urology · 400d
Cleared Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813
Nipro Medical Corp.
Gastroenterology & Urology · 74d
Cleared Apr 10, 2000
MODIFICATION TO JMS APHERESIS NEEDLE
K000843
Jms Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845
Jms Co., Ltd.
Gastroenterology & Urology · 26d

About Product Code FIE - Regulatory Context

510(k) Submission Activity

80 total 510(k) submissions under product code FIE since 1977, with 80 receiving FDA clearance (average review time: 122 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FIE Product Code

Recent submissions under FIE have taken an average of 179 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.

FIE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →