Product Code: FIB FDA class 2 21 CFR 876.5820

Protector, Transducer, Dialysis

Gastroenterology, Urology

The Dialysis Transducer Protector is a barrier device placed in the pressure monitoring line of a hemodialysis circuit to prevent blood or dialysate contamination of the pressure transducer, protecting the machine and reducing infection risk. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is considered life-sustaining or life-supporting. The product code is FIB, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FIB
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240164	NovaLine SP-C35 Transducer Protector (956007)	Jun 28, 2024	Substantially Equivalent	Bain Medical Equipment (Guangzhou) Co., Ltd.
K072988	NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1	Feb 21, 2008	Substantially Equivalent	Nipro Medical Corporation
K001971	HEMODIALYSIS TUBING SETS	May 24, 2001	Substantially Equivalent	Ofi Biomedica S.P.A.
K010264	NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET	Apr 27, 2001	Substantially Equivalent	Nipro Medical Corp.
K001465	NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET	Dec 05, 2000	Substantially Equivalent	Nipro Medical Corp.
K003445	FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2	Dec 01, 2000	Substantially Equivalent	Fresenius Medical Care North America
K000702	BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR	Jun 07, 2000	Substantially Equivalent	Fresenius Medical Care North America
K983076	MEDISYSTEMS TRANSDUCER PROTECTOR	Nov 25, 1998	Substantially Equivalent	Medisystems Corp.
K964337	BETTER-BLADDER (BB)	May 23, 1997	Substantially Equivalent	Circulatory Technology, Inc.
K970536	MEDISYSTEMS TRANDUCER PROTECTOR	May 12, 1997	Substantially Equivalent	Medisystems Corp.
K934069	MILLEX, DUALEX (PLUS, ULTRA)	Apr 21, 1994	Substantially Equivalent	Millipore Corp.
K925978	MPC-80 TRANSDUCER	Jan 14, 1994	Substantially Equivalent	Molded Products, Inc.
K915593	TRANSDUCER PROTECTOR	Jul 01, 1992	Substantially Equivalent	United Pharmaceutical and Medical Supply Co.
K912394	TRANSDUCER PROTECTOR	Aug 30, 1991	Substantially Equivalent	Filtertek, Inc.
K911658	DIALYSIS TRANDSDUCER PROTECTOR	Aug 12, 1991	Substantially Equivalent	Tico Medical Instruments, Inc.
K910821	TRANSDUCER PROTECTOR	Aug 12, 1991	Substantially Equivalent	Gelman Sciences, Inc.
K904912	TRANSDUCER PROTECTOR	Jan 04, 1991	Substantially Equivalent	Filtertek, Inc.
K902788	CLEM TM	Sep 12, 1990	Substantially Equivalent	Arbo Medical, Inc.
K901409	TRANSDUCER PROTECTOR	Jul 27, 1990	Substantially Equivalent	Filtertek, Inc.
K901996	FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR	Jun 01, 1990	Substantially Equivalent	Filtertek, Inc.
K900841	HEMODIALYSIS TRANSDUCER PROTECTOR	May 15, 1990	Substantially Equivalent	Mediflex Intl.
K895856	MEDISYSTEMS TRANSDUCER PROTECTOR	Nov 24, 1989	Substantially Equivalent	Medisystems Corp.
K895281	TRANSDUCER PROTECTOR	Nov 08, 1989	Substantially Equivalent	Filtertek, Inc.
K891752	DA-46 FLUID BARRIER	Apr 07, 1989	Substantially Equivalent	Akcess Medical Products, Inc.
K870394	HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS	Mar 03, 1987	Substantially Equivalent	Clinical Connections, Inc.
K863496	MEDIFLEX TRANSDUCER PROTECTOR	Sep 23, 1986	Substantially Equivalent	Mediflex Intl.
K862015	O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER	Jul 22, 1986	Substantially Equivalent	Bipore, Inc.
K851734	OMNIMED SUPERIOR TRANSDUCER PROTECTOR	May 23, 1985	Substantially Equivalent	Omni Intl., Inc.
K851428	TRANDUCER PROTECTOR	May 21, 1985	Substantially Equivalent	Galvin Industries, Inc.
K851230	GAMBRO PRESSURE MONITOR GUARDS	Apr 09, 1985	Substantially Equivalent	Gambro, Inc.
K821268	TRANSDUCER FILTER	Jun 23, 1982	Substantially Equivalent	Cp Medical
K812162	HEMODIALYSIS TRANSDUCER PROTECTOR	Sep 24, 1981	Substantially Equivalent	Membrana
K812107	RENALAB TRANSDUCER PROTECTOR, .22 MICRON	Aug 20, 1981	Substantially Equivalent	Renalab
K811859	BACTASHIELD	Aug 07, 1981	Substantially Equivalent	Tri-Med, Inc.
K811892	CORDIS DOW SERA FLO TM TRANSDUCER PROT	Jul 31, 1981	Substantially Equivalent	Cordis Corp.