MPB · Class II · 21 CFR 876.5540

FDA Product Code MPB: Catheter, Hemodialysis, Non-implanted

Leading manufacturers include Medical Components, Inc., Quinton, Inc. and C.R. Bard, Inc..

38
Total
38
Cleared
225d
Avg days
1987
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 145d recently vs 227d historically

FDA 510(k) Cleared Catheter, Hemodialysis, Non-implanted Devices (Product Code MPB)

38 devices
1–24 of 38
Cleared Aug 12, 2025
14F Duo-Flow® Side X Side Double Lumen Catheter
K250836
Medical Components, Inc.
Gastroenterology & Urology · 145d
Cleared Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
K200426
Health Line International Corporation
Gastroenterology & Urology · 307d
Cleared Apr 23, 2020
Duo-Flow Side x Side Double Lumen Catheter
K192807
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 205d
Cleared Jan 17, 2020
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
K192302
Covidien, LLC
Gastroenterology & Urology · 147d
Cleared Apr 04, 2017
Zenysis Short-Term Dialysis Catheter
K163458
C.R. Bard, Inc.
Gastroenterology & Urology · 116d
Cleared Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
K161504
Cook Incorporated
Gastroenterology & Urology · 219d
Cleared Jan 05, 2016
Zenysis Short-Term Dialysis Catheter
K153190
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
K122091
Cook, Inc.
Gastroenterology & Urology · 378d
Cleared Apr 04, 2012
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
K120674
Covidien
Gastroenterology & Urology · 30d
Cleared Feb 12, 2009
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
K090102
C.R. Bard, Inc.
Gastroenterology & Urology · 28d
Cleared Sep 07, 2007
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
K071145
Nipro Medical Corporation
Gastroenterology & Urology · 136d
Cleared Jul 30, 2003
NIAGARA TEMPORARY DUAL LUMEN CATHETERS
K030268
C.R. Bard, Inc.
Gastroenterology & Urology · 184d
Cleared Apr 13, 2001
NIAGARA SLIM-CATH
K010778
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 14, 2000
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
K993933
Arrow Intl., Inc.
Gastroenterology & Urology · 301d
Cleared Nov 10, 1999
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
K991320
Medical Components, Inc.
Gastroenterology & Urology · 205d
Cleared Jun 10, 1999
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
K980438
Medical Components, Inc.
Gastroenterology & Urology · 491d
Cleared Jun 08, 1999
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
K983511
Medical Components, Inc.
Gastroenterology & Urology · 244d
Cleared May 26, 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431
Arrow Intl., Inc.
Gastroenterology & Urology · 30d
Cleared May 18, 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022
Arrow Intl., Inc.
Gastroenterology & Urology · 187d
Cleared Apr 15, 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
K974236
Medical Components, Inc.
Gastroenterology & Urology · 519d
Cleared Mar 18, 1997
KENDALL DUAL LUMEN CATHETER
K963446
Kendall Healthcare Products Co. Div.Of Tyco Health
Gastroenterology & Urology · 196d
Cleared Sep 17, 1996
BRAUN HEMODIALYSIS CATHETER
K952660
B.Braun Medical, Inc.
Gastroenterology & Urology · 463d
Cleared Sep 13, 1996
MAHURKAR 8 FR DUAL LEMEN CATHETER
K955002
Quinton, Inc.
Gastroenterology & Urology · 317d
Cleared Sep 25, 1995
TWIN SILICONE CATHETER
K923691
Medical Components, Inc.
Gastroenterology & Urology · 1159d

About Product Code MPB - Regulatory Context

510(k) Submission Activity

38 total 510(k) submissions under product code MPB since 1987, with 38 receiving FDA clearance (average review time: 225 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 - MPB Product Code

Recent submissions under MPB have taken an average of 145 days to reach a decision - down from 227 days historically, suggesting improved FDA processing for this classification.

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