Product code FIE— Gastroenterology, Urology
JMS APHERESIS NEEDLE
- Classification name
- Needle, Fistula
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 80
- First cleared
- Most recent
Market context for product code FIE
FDA has cleared devices under product code FIE between 1977 and 2026, filed by 41 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2022
- 2018
- 2017
- 2015
- 2014
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2005
- 2004
Top applicants under product code FIE
Adverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FIE
- K253469 — Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more
- K251877 — JMS CAVEO A.V. Fistula Needle Set
- K213015 — DORA Disposable A.V. Fistula Needle Sets
- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K163025 — DORA Disposable A.V. Fistula Needle Sets
- K151017 — JMS Harmony A.V. Fistula Needle Set
- K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
- K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
- K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
- K112734 — APLAN A.V. FISTULA NEEDLE SET
- K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2
- K111948 — WINGEATER V2
- K110157 — SYSLOC MINI V3
- K100520 — NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
- K093637 — JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
- K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
- K082882 — A.V. FISTULA BLUNT NEEDLE SET
- K062953 — MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
- K063368 — NIPRO BIOHOLE NEEDLE
- K063721 — NIPRO SAFETOUCH II GAMMA
- K052267 — SUPERCATH V
- K051814 — JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
- K040247 — PLUME SAFETY AVF NEEDLE
- K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
- K013384 — SHARGHP A.V. FISTULA NEEDLE SET
- K013037 — EXCEL A.V FISUTAL NEEDLE SET
- K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
- K003123 — RENAX A.V. FISTULA NEEDLE SETS
- K002813 — NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
- K001496 — A.V. FISTULA NEEDLE
- K000843 — MODIFICATION TO JMS APHERESIS NEEDLE
- K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
- K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS
- K993118 — BIOTEQUE A.V. FISTULA NEEDLE SET
- K992653 — SHELLY PROTECTED AV FISTULA NEEDLE
- K990470 — JMS A. V. FISTULA NEEDLE SET
- K990510 — JMS APHERESIS NEEDLE
- K991623 — NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
- K974902 — JMS APHERESIS NEEDLE
- K970962 — JMS AV FISTULA NEEDLE
- K955182 — NIPRO ARTERIAL VENOUS FISTULA NEEDLE
- K945850 — BRAUN DIACAN(R) FISTULA NEEDLES
- K932074 — MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
- K915174 — JMS APHERESIS NEEDLE
- K903440 — VIVAMED FISTULA NEEDLE
- K911199 — JMS AV FISTULA NEEDLES
- K910734 — MEDISYSTEMS HEMODIALYSIS FISTULA SET
- K902564 — NEEDLE, DIALYSIS
- K903945 — EXEL A-V FISTULA SET
- K900125 — ARTERIOVENOUS FISTULA SETS
- K891062 — TERUMO AV FISTULA NEEDLE SET
- K880726 — JMS APHERESIS NEEDLE
- K862002 — MEDISYSTEMS PHERESIS NEEDLE
- K854773 — SUPERCATH A.V. FISTULA
- K860789 — JMD AV FISTULA NEEDLE (MODIFICATION)
- K860449 — MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
- K860241 — JMS AV FISTULA NEEDLE
- K854951 — PLUME Y SET
- K851453 — HOSPAL FISTULA NEEDLE
- K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
- K832136 — DUAL FLOW NEEDLE
- K812621 — DELTA-A.V. FISTULA CANNULATION SET
- K811838 — MEDISYSTEMS FISTULA NEEDLE
- K802956 — GAMBRO A-V FISTULA NEEDLE SET
- K801966 — HEMO-CATH II KIDNEY DIALYSIS CATHETER
- K801618 — ARGYLE A-V MEDI-WING HEMODIALYSIS SET
- K801632 — THE BELLCO FISTULA NEEDLES
- K791489 — VITAL CATHETER
- K791490 — UNIPUNCTURE CATHETER
- K782021 — A.V. FISTULA NEEDLE SET
- K772362 — AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
- K771490 — A.V. FISTULA NEEDLE SET (#344)
- K771491 — A.V. FISTULA NEEDLE SET (#364)
- K771492 — A.V. FISTULA NEEDLE SET (#351)
- K771493 — A.V. FISTULA NEEDLE SET (#341)
- K771494 — A.V. FISTULA NEEDLE SET (354)
- K771495 — A.V. FISTULA NEEDLE SET (#361)
- K771206 — AV FISTULA NEEDLE SET
- K770864 — HEMODIALYSIS FISTULA SET
- K770699 — NEEDLE SET, A-V FISTULA
Data sourced from openFDA. This site is unofficial and independent of the FDA.