FDA Product Code FIB: Protector, Transducer, Dialysis
Leading manufacturers include Fresenius Medical Care North America, Millipore Corp. and Nipro Medical Corporation.
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
Cleared
Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
Bain Medical Equipment (Guangzhou) Co., Ltd.
Gastroenterology & Urology
158d
Cleared
Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
Nipro Medical Corporation
Gastroenterology & Urology
121d
Cleared
Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
Fresenius Medical Care North America
Gastroenterology & Urology
25d
Cleared
Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
Fresenius Medical Care North America
Gastroenterology & Urology
98d
Cleared
Apr 21, 1994
MILLEX, DUALEX (PLUS, ULTRA)
Millipore Corp.
Gastroenterology & Urology
244d
Cleared
Aug 12, 1991
TRANSDUCER PROTECTOR
Gelman Sciences, Inc.
Gastroenterology & Urology
167d
Cleared
Apr 07, 1989
DA-46 FLUID BARRIER
Akcess Medical Products, Inc.
Gastroenterology & Urology
15d
Cleared
Apr 09, 1985
GAMBRO PRESSURE MONITOR GUARDS
Gambro, Inc.
Gastroenterology & Urology
14d
Cleared
Jun 23, 1982
TRANSDUCER FILTER
Cp Medical
Gastroenterology & Urology
51d
Cleared
Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
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.