Atlas FDA

FJK

77 FDA 510(k) clearances · Product code

88 daysmedian time to decision
348 days90th percentile
77clearances measured

FDA profile

Official device name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 188 · 2022: 362 · 2023: 585 · 2024: 417 · 2025: 1,494 · 2026: 1,159
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NovaLine Tubing Set for Hemodialysis (BL 124) (K252423)Bain Medical Equipment (Guangzhou) Co., Ltd.2026-05-15
VITAL Tubing Sets for Hemodialysis (K251341)Vital Healthcare Sdn. Bhd.2026-01-16
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (K251442)Ningbo Tianyi Medical Appliance Co., Ltd.2025-10-02
Moda-flx Hemodialysis Systemâ„¢ Cartridge (102121-001 ) (K243607)Diality, Inc.2024-12-20
CombiSet Hemodialysis Blood Tubing Set (K213992)Fresenius Medical Care Renal Therapies Group, LLC2023-05-31
Tablo Cartridge (K210782)Outset Medical, Inc.2021-11-26
SANSIN Tubing Sets for Hemodialysis (K202796)Jiangxi Sanxin Medtec Co., Ltd.2021-09-06
NovaLine Tubing Sets for Hemodialysis (K201866)Bain Medical Equipment (Guangzhou) Co., Ltd.2021-03-10
Dimesol Tubing Sets for Hemodialysis (K171952)Dimesol, Inc.2018-03-30
DORA Tubing Sets for Hemodialysis (K161582)Bain Medical Equipment (Guangzhou) Co., Ltd.2017-06-16
Oxyless Blood Tubing Set (K150304)Oxyless, Ltd.2016-02-24
TABLO CARTRIDGE (K140841)Home Dialysis Plus2014-09-11
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET (K112628)Nipro Medical Corporation2012-09-28
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS (K120823)Fresenius Medical Care North America, Design Cente2012-06-15
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (K100364)Gambro Renal Products, Inc.2010-11-03
BLOOD TUBING SETS (STERILE FLUID PATH) (K090255)Nxstage Medical, Inc.2009-02-10
BLOOD TUBING SETS (STERILE FLUID PATH) (K080807)Nxstage Medical, Inc.2008-07-18
GAMBRO CARTRIDGE BLOOD SETS (K070414)Gambro Renal Products2007-10-12
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 (K072024)Nipro Medical Corp.2007-10-04
EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE (K063293)Edwards Lifesciences Services GmbH2007-03-23
GAMBRO QUICKSET BLOODLINES (K063290)Gambro Renal Products2007-01-30
JMS BLOOD TUBING SETS (K032975)Jms North America Corp.2004-08-16
RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET (K014140)Sunder Biomedical Tech. Co., Ltd.2002-11-18
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK (K013634)Bioteque Corp.2002-07-09
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS (K012242)Fresenius Medical Care North America2001-08-16
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 (K001873)Fresenius Medical Care North America2000-07-28
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) (K001107)Fresenius Medical Care North America2000-06-23
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 (K000451)Fresenius Medical Care North America2000-05-09
EXEL I.V. BLOOD LINE SET (K992039)Exelint Intl. Co.2000-02-10
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930)Bioteque Corp.2000-02-09
EXTRACORPOREAL BLOOD CIRCUIT (K982340)Haidylena Medical Egypt1999-04-30
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR (K983559)Icu Medical, Inc.1998-12-24
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET (K971313)National Medical Care, Inc.1997-10-27
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME (K971687)National Medical Care, Inc.1997-07-29
COMBILINES HEMODIALYSIS BLOOD TUBING SET (K962081)National Medical Care, Medical Products Div., Inc.1996-11-01
ARTERIAL VENOUS BLOOD TUBING SET (K953823)Medisystems Corp.1996-09-23
BRAUN HEMODIALYSIS BLOOD CIRCUITS (K952631)B.Braun Medical, Inc.1996-04-30
TS 564/PF (K950247)Bressler, Amery & Ross1995-11-17
CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 (K921597)Haemotronic, Inc.1995-02-24
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS (K934803)Baxter Healthcare Corp1993-12-17
HEMODIALYSIS BLOOD TUBING SET (K920797)National Medical Care, Medical Products Div., Inc.1992-09-21
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS (K913526)Althin Medical AB an Affiliate of Baxter Intl1991-11-01
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET (K910558)Terumo Medical Corp.1991-08-07
HEMODIALYSIS SYSTEM AND ACCESSORY (K902426)Gainor Medical Europe, Ltd.1990-11-20
NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 (K903021)National Medical Care, Medical Products Div., Inc.1990-08-14
ARTERIAL/VENOUS BLOODLINES (K901688)National Medical Care, Medical Products Div., Inc.1990-08-02
HAEMOTRONIC BLOOD LINE SET (K896407)Healthcare Suppliers, Inc.1990-04-25
BIOPRIME TM KIT (K892932)Hospal1989-06-22
BLOOD TUBING SET (K884243)Mediflex Intl.1988-12-08
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE (K870722)National Medical Care, Medical Products Div., Inc.1988-09-14
KAWASUMI BLOOD TUBING LINE (K873516)Kawasumi Laboratories Co., Ltd.1987-10-05
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (K873455)Dravon Medical, Inc.1987-09-14
SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS (K864784)Cd Medical, Inc.1987-01-20
ERIKA ARTERIAL LINE 03-9625-9 (K860740)National Medical Care, Medical Products Div., Inc.1986-03-14
FRESENIUS DISPOSABLE BLOOD LINES (K853851)Seratronics, Inc.1985-11-12
ASA BLOOD TUBING LINES (K854271)Organon Teknika Corp.1985-11-05
ERIKA ARTERIAL LINE 03-9837-0 (K853962)National Medical Care, Medical Products Div., Inc.1985-10-18
BLOOD TUBING SET (K852605)Medflex International, Inc.1985-07-29
HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES (K851236)Infarkem Corp.1985-07-26
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 (K852309)Erika, Inc.1985-07-26
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (K831424)Extracorporeal Medical Specialities, Inc.1983-10-14
PLASMA THERAPY TUBESET-E100 SERIES (K831747)Parker Hannifin Corp.1983-06-30
BLOOD LINE SETS FOR HEMOFILTRATION (K830677)Gambro, Inc.1983-04-12
TS-180 SERIES TUBING SET (K821138)Extracorporeal Medical Specialities, Inc.1982-05-10
MALE LUER CONNECTOR & HINGED CAP (K820169)Extracorporeal Medical Specialities, Inc.1982-02-05
ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE (K812685)Ericka1981-09-29
MEDISYSTEM NEGATIVE PRESSURE (K811839)Medisystems Corp.1981-09-08
ERIKA HEPARIN INFUSION ADAPTOR (K810824)Erika, Inc.1981-04-17
ERIKA EXTENSION SETS (K810823)Erika, Inc.1981-04-17
ARTERIOVENOUS BLOOD TUBING SETS (K802874)Extracorporeal Medical Specialities, Inc.1980-11-25
COBE HEMOFLO BLOOD TUBING SETS (K801211)Cobe Laboratories, Inc.1980-07-14
GAMBRO G SERIES BLOOD LINE SETS FOR HEM. (K801016)Gambro, Inc.1980-05-30
ERIKA NEGATIVE PRESSURE VENOUS BL SETS (K792054)Erika, Inc.1979-12-06
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD (K792053)Erika, Inc.1979-12-06
ARTERIOVENOUS BLOOD TUBING SETS (K780681)Extracorporeal Medical Specialities, Inc.1978-06-14
CLIRANS BLOOD LINES SET (K771693)Terumo America, Inc.1977-09-20
ARTERIOVENOUS BLOOD TUBING SETS (K761326)Extracorporeal Medical Specialities, Inc.1977-01-10

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