FIE · Class II · 21 CFR 876.5540

FDA Product Code FIE: Needle, Fistula

Leading manufacturers include Sorensen Research, Hospal Medical Corp. and Sherwood Medical Co..

79
Total
79
Cleared
120d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 58d recently vs 121d historically

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

79 devices
1–24 of 79
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 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 Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520
Nipro Medical Corporation
Gastroenterology & Urology · 22d
Cleared Jan 31, 1990
ARTERIOVENOUS FISTULA SETS
K900125
Baxter Healthcare Corp
Gastroenterology & Urology · 22d
Cleared Jun 22, 1989
TERUMO AV FISTULA NEEDLE SET
K891062
Terumo Medical Corp.
Gastroenterology & Urology · 113d
Cleared Jan 08, 1986
PLUME Y SET
K854951
Hospal Medical Corp.
Gastroenterology & Urology · 29d
Cleared Apr 29, 1985
HOSPAL FISTULA NEEDLE
K851453
Hospal Medical Corp.
Gastroenterology & Urology · 18d
Cleared Oct 14, 1983
DUAL FLOW NEEDLE
K832136
Travenol Laboratories, S.A.
Gastroenterology & Urology · 105d
Cleared Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
K802956
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Sep 26, 1980
HEMO-CATH II KIDNEY DIALYSIS CATHETER
K801966
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Aug 13, 1980
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618
Sherwood Medical Co.
Gastroenterology & Urology · 29d
Cleared Oct 26, 1979
VITAL CATHETER
K791489
Hospal Medical Corp.
Gastroenterology & Urology · 84d
Cleared Oct 26, 1979
UNIPUNCTURE CATHETER
K791490
Hospal Medical Corp.
Gastroenterology & Urology · 84d
Cleared Mar 21, 1979
A.V. FISTULA NEEDLE SET
K782021
Cordis Corp.
Gastroenterology & Urology · 106d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#344)
K771490
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#364)
K771491
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#351)
K771492
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#341)
K771493
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (354)
K771494
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#361)
K771495
Sorensen Research
Gastroenterology & Urology · 11d

About Product Code FIE - Regulatory Context

510(k) Submission Activity

79 total 510(k) submissions under product code FIE since 1977, with 79 receiving FDA clearance (average review time: 120 days).

Submission volume has increased in recent years - 1 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 58 days to reach a decision - down from 121 days historically, suggesting improved FDA processing for this classification.

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