FIB · Class II · 21 CFR 876.5820

FDA Product Code FIB: Protector, Transducer, Dialysis

Leading manufacturers include Medisystems Corp., Fresenius Medical Care North America and Nipro Medical Corp..

35
Total
35
Cleared
102d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Protector, Transducer, Dialysis Devices (Product Code FIB)

35 devices
1–24 of 35
Cleared Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
K240164
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology · 158d
Cleared Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988
Nipro Medical Corporation
Gastroenterology & Urology · 121d
Cleared Apr 27, 2001
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
K010264
Nipro Medical Corp.
Gastroenterology & Urology · 88d
Cleared Dec 05, 2000
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
K001465
Nipro Medical Corp.
Gastroenterology & Urology · 209d
Cleared Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445
Fresenius Medical Care North America
Gastroenterology & Urology · 25d
Cleared Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702
Fresenius Medical Care North America
Gastroenterology & Urology · 98d
Cleared Nov 25, 1998
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076
Medisystems Corp.
Gastroenterology & Urology · 84d
Cleared May 23, 1997
BETTER-BLADDER (BB)
K964337
Circulatory Technology, Inc.
Gastroenterology & Urology · 204d
Cleared May 12, 1997
MEDISYSTEMS TRANDUCER PROTECTOR
K970536
Medisystems Corp.
Gastroenterology & Urology · 89d
Cleared Apr 21, 1994
MILLEX, DUALEX (PLUS, ULTRA)
K934069
Millipore Corp.
Gastroenterology & Urology · 244d
Cleared Aug 12, 1991
TRANSDUCER PROTECTOR
K910821
Gelman Sciences, Inc.
Gastroenterology & Urology · 167d
Cleared Nov 24, 1989
MEDISYSTEMS TRANSDUCER PROTECTOR
K895856
Medisystems Corp.
Gastroenterology & Urology · 53d
Cleared Apr 07, 1989
DA-46 FLUID BARRIER
K891752
Akcess Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 09, 1985
GAMBRO PRESSURE MONITOR GUARDS
K851230
Gambro, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 23, 1982
TRANSDUCER FILTER
K821268
Cp Medical
Gastroenterology & Urology · 51d
Cleared Aug 07, 1981
BACTASHIELD
K811859
Tri-Med, Inc.
Gastroenterology & Urology · 37d
Cleared Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892
Cordis Corp.
Gastroenterology & Urology · 30d

About Product Code FIB - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code FIB since 1981, with 35 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.