Atlas FDA

FIE

80 FDA 510(k) clearances · Product code

84 daysmedian time to decision
302 days90th percentile
80clearances measured

FDA profile

Official device name
Needle, Fistula
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2017: 14 · 2018: 16 · 2019: 21 · 2023: 58 · 2025: 33 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) (K253469)Mozarc Medical Us, LLC2026-08-06
JMS CAVEO A.V. Fistula Needle Set (K251877)JMS North America Corporation2025-08-15
DORA Disposable A.V. Fistula Needle Sets (K213015)Bain Medical Equipment (Guangzhou) Co., Ltd.2022-04-08
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) (K171505)Dimesol, Inc.2018-05-17
DORA Disposable A.V. Fistula Needle Sets (K163025)Bain Medical Equipment (Guangzhou) Co., Ltd.2017-07-20
JMS Harmony A.V. Fistula Needle Set (K151017)JMS North America Corporation2015-05-13
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (K131950)Summit International Medical Technologies, Inc.2015-01-16
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (K142564)JMS North America Corporation2014-12-23
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO (K134019)Nxstage Medical, Inc.2014-09-11
APLAN A.V. FISTULA NEEDLE SET (K112734)Aplan Well Enterprise Co., Ltd.2012-04-24
JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (K112178)JMS North America Corporation2011-10-27
WINGEATER V2 (K111948)JMS North America Corporation2011-10-24
SYSLOC MINI V3 (K110157)JMS North America Corporation2011-02-11
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER (K100520)Nipro Medical Corporation2010-03-17
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 (K093637)Jms North America Corp.2010-02-09
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (K093985)Nipro Medical Corp.2010-01-22
A.V. FISTULA BLUNT NEEDLE SET (K082882)Jms North America Corp.2009-01-21
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE (K062953)Medisystems Corp.2007-02-12
NIPRO BIOHOLE NEEDLE (K063368)Nipro Medical Corp.2007-02-05
NIPRO SAFETOUCH II GAMMA (K063721)Nipro Medical Corp.2007-01-12
SUPERCATH V (K052267)Togo Medikit Co., Ltd.2006-10-27
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET (K051814)Jms North America Corp.2005-08-04
PLUME SAFETY AVF NEEDLE (K040247)Jms North America Corp.2004-03-03
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS (K023162)Fresenius Medical Care2003-03-20
SHARGHP A.V. FISTULA NEEDLE SET (K013384)Shargh Pharmaceutical Co., Inc.2002-01-07
EXCEL A.V FISUTAL NEEDLE SET (K013037)Exelint Intl. Co.2001-12-07
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (K002352)Jms Co., Ltd.2001-09-06
RENAX A.V. FISTULA NEEDLE SETS (K003123)Sunder Biomedical Tech. Co., Ltd.2001-05-04
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE (K002813)Nipro Medical Corp.2000-11-21
A.V. FISTULA NEEDLE (K001496)Exelint International, Co.2000-08-01
MODIFICATION TO JMS APHERESIS NEEDLE (K000843)Jms Co., Ltd.2000-04-10
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (K000845)Jms Co., Ltd.2000-04-10
MEDISYSTEMS BUTTONHOLE NEEDLE SETS (K990803)Medisystems Corp.2000-01-06
BIOTEQUE A.V. FISTULA NEEDLE SET (K993118)Bioteque Corp.1999-12-17
SHELLY PROTECTED AV FISTULA NEEDLE (K992653)Diasol, Inc.1999-10-27
JMS APHERESIS NEEDLE (K990510)Jms Co., Ltd.1999-08-30
JMS A. V. FISTULA NEEDLE SET (K990470)Jms Co., Ltd.1999-08-30
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA (K991623)Nipro Medical Corp.1999-08-09
JMS APHERESIS NEEDLE (K974902)Jms Co., Ltd.1998-03-30
JMS AV FISTULA NEEDLE (K970962)Jms Co., Ltd.1997-08-07
NIPRO ARTERIAL VENOUS FISTULA NEEDLE (K955182)Nissho Corp.1996-06-04
BRAUN DIACAN(R) FISTULA NEEDLES (K945850)B. Braun of America, Inc.1995-10-06
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD (K932074)Medisystems Corp.1994-02-18
JMS APHERESIS NEEDLE (K915174)Jms Co., Ltd.1993-03-02
VIVAMED FISTULA NEEDLE (K903440)S.S. Ent.1992-04-20
JMS AV FISTULA NEEDLES (K911199)Jms Co., Ltd.1991-08-28
MEDISYSTEMS HEMODIALYSIS FISTULA SET (K910734)Medisystems Corp.1991-06-20
NEEDLE, DIALYSIS (K902564)Gainor Medical Europe, Ltd.1991-03-01
EXEL A-V FISTULA SET (K903945)Exel Intl.1990-11-20
ARTERIOVENOUS FISTULA SETS (K900125)Baxter Healthcare Corp1990-01-31
TERUMO AV FISTULA NEEDLE SET (K891062)Terumo Medical Corp.1989-06-22
JMS APHERESIS NEEDLE (K880726)Jms Co., Ltd.1988-03-16
MEDISYSTEMS PHERESIS NEEDLE (K862002)Medisystems Corp.1986-06-27
SUPERCATH A.V. FISTULA (K854773)Togo Medikit Co., Ltd.1986-04-08
JMD AV FISTULA NEEDLE (MODIFICATION) (K860789)Jms Co., Ltd.1986-03-18
MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE (K860449)Top Corp.1986-02-26
JMS AV FISTULA NEEDLE (K860241)Jms Co., Ltd.1986-02-05
PLUME Y SET (K854951)Hospal Medical Corp.1986-01-08
HOSPAL FISTULA NEEDLE (K851453)Hospal Medical Corp.1985-04-29
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE (K844343)Top Surgical Manufacturers Co.1985-01-08
DUAL FLOW NEEDLE (K832136)Travenol Laboratories, S.A.1983-10-14
DELTA-A.V. FISTULA CANNULATION SET (K812621)Amisco Trading Corp.1981-09-24
MEDISYSTEMS FISTULA NEEDLE (K811838)Medisystems Corp.1981-09-08
GAMBRO A-V FISTULA NEEDLE SET (K802956)Gambro, Inc.1980-12-22
HEMO-CATH II KIDNEY DIALYSIS CATHETER (K801966)Medical Components, Inc.1980-09-26
ARGYLE A-V MEDI-WING HEMODIALYSIS SET (K801618)Sherwood Medical Co.1980-08-13
THE BELLCO FISTULA NEEDLES (K801632)Bellco Artifidial Organ Spec., Inc.1980-08-04
VITAL CATHETER (K791489)Hospal Medical Corp.1979-10-26
UNIPUNCTURE CATHETER (K791490)Hospal Medical Corp.1979-10-26
A.V. FISTULA NEEDLE SET (K782021)Cordis Corp.1979-03-21
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS (K772362)Terumo America, Inc.1978-03-17
A.V. FISTULA NEEDLE SET (#364) (K771491)Sorensen Research1977-08-16
A.V. FISTULA NEEDLE SET (#351) (K771492)Sorensen Research1977-08-16
A.V. FISTULA NEEDLE SET (#361) (K771495)Sorensen Research1977-08-16
A.V. FISTULA NEEDLE SET (#341) (K771493)Sorensen Research1977-08-16
A.V. FISTULA NEEDLE SET (354) (K771494)Sorensen Research1977-08-16
A.V. FISTULA NEEDLE SET (#344) (K771490)Sorensen Research1977-08-16
AV FISTULA NEEDLE SET (K771206)Terumo America, Inc.1977-07-15
HEMODIALYSIS FISTULA SET (K770864)Venospital, Inc.1977-06-24
NEEDLE SET, A-V FISTULA (K770699)Medical Disposables Intl., Inc.1977-06-14

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