Product Code: FPB FDA class 2 21 CFR 880.5440

Filter, Infusion Line

General Hospital

The Infusion Line Filter is a component installed in an intravenous administration set to remove particulates, microorganisms, or air bubbles from fluids before they enter the patient's bloodstream. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPB, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code FPB in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: FPB
Device Class: FDA class 2
Regulation Number: 880.5440
Medical Specialty: General Hospital
Review Panel: HO
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 98 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233277	Filter Needle for Single Use	May 10, 2024	Substantially Equivalent	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
K143583	Cathivex ¿GV filter units	Aug 11, 2015	Substantially Equivalent	Merck Millipore , Ltd.
K113227	NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER	Dec 08, 2011	Substantially Equivalent	Baxter Healthcare Corp
K021293	ARTERIA BLOOD FILTER	Aug 22, 2002	Substantially Equivalent	Arteria Medical Science, Inc.
K993379	PALL SUPOR AEF FILTER	Dec 16, 1999	Substantially Equivalent	Pall Corp.
K974661	0.2 U BACTERIAL FILTER	Feb 11, 1998	Substantially Equivalent	Sims Deltec, Inc.
K964283	AUTOPRIME	Jan 22, 1997	Substantially Equivalent	Arbor Technologies, Inc.
K954331	PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)	Jan 09, 1997	Substantially Equivalent	Pall Biomedical Products Co.
K933523	I.V. FILTER SET	May 19, 1995	Substantially Equivalent	Mediziv Medical Products 1987 , Ltd.
K941628	40 MICRON BLOOD TRANSFUSION FILTER	Feb 16, 1995	Substantially Equivalent	Douglas Medical Products Corp.
K942625	1.2 MICRON AIR ELIMINATING FILTER	Oct 07, 1994	Substantially Equivalent	The Medi-Dose Group
K943127	PHARMASSURE LARGE VOLUME TRANSFER FILTERS	Sep 29, 1994	Substantially Equivalent	Gelman Sciences, Inc.
K942532	2 MICRON AIR ELIMINATING FILTER	Aug 17, 1994	Substantially Equivalent	Medi-Dose, Inc.
K941684	IVEX-2 EXTENSION SET WITH Y-INJECTION SITE	Aug 03, 1994	Substantially Equivalent	Abbott Laboratories
K942275	VIAL VENT FILTER	Jul 26, 1994	Substantially Equivalent	Gelman Sciences, Inc.
K940980	CHARGED SUPOR(R) FILTER EXTENSION SET	Jul 14, 1994	Substantially Equivalent	B. Braun of America, Inc.
K933869	EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER	Apr 26, 1994	Substantially Equivalent	Baxter Healthcare Corp
K940293	1.2 MICRON FINAL FILTER WITH EXTENSION TUBE	Mar 28, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K933294	MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES	Feb 09, 1994	Substantially Equivalent	Aesculap, Inc.
K935641	0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS	Jan 28, 1994	Substantially Equivalent	Evans Medical, Inc.
K932301	FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER	Nov 10, 1993	Substantially Equivalent	Baxter Healthcare Corp
K931441	FENWAL 40 MICRON TRANSFUSION FILTER	Sep 21, 1993	Substantially Equivalent	Baxter Healthcare Corp
K920736	IVEX-HP96 EXTENDED LIFE FILTER SET	Apr 23, 1993	Substantially Equivalent	Abbott Laboratories
K913308	IVEX-TPN EXTENSION FILTER SET	Jan 15, 1992	Substantially Equivalent	Abbott Laboratories
K912848	I.V. FILTER EXTENSION SET	Nov 29, 1991	Substantially Equivalent	Filtertek, Inc.
K905794	PALL 3N1 FILTER	Jun 13, 1991	Substantially Equivalent	Pall Biomedical Products Co.
K911451	I.V. EXTENDER SET	Jun 06, 1991	Substantially Equivalent	Filtertek, Inc.
K896333	CMS IV FILTERS	Jan 11, 1990	Substantially Equivalent	Churchill Medical Systems, Inc.
K896292	1.2 MICRON FILTER WITH IV SET	Dec 08, 1989	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K894954	.22 & 1.2 MICRON IV FILTERS	Nov 13, 1989	Substantially Equivalent	Churchill Medical Systems, Inc.
K880605	LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER	May 26, 1988	Substantially Equivalent	Miles Laboratories, Inc.
K880026	CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS	Apr 14, 1988	Substantially Equivalent	Churchill Corp.
K880025	CHURCHILL 0.22 MICRON LIQUID FILTER SETS	Apr 14, 1988	Substantially Equivalent	Churchill Corp.
K880027	CHURCHILL 1.2 MICRON LIQUID FILTER SET	Apr 13, 1988	Substantially Equivalent	Churchill Corp.
K872634	CUTTER PUREFLO PLUS IV FILTER	Aug 04, 1987	Substantially Equivalent	Miles Laboratories, Inc.
K865029	CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER	Apr 17, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K864113	CLYDE (TM) FILTRATION SYSTEM	Feb 04, 1987	Substantially Equivalent	Arbor Technologies, Inc.
K861644	CRITIKON 48-HOUR AIR ELIMINATING FILTER	Jul 22, 1986	Substantially Equivalent	Critikon Company, LLC
K860372	FAST FLOW XX (AQUEOUS SOLUTION FILTER)	May 30, 1986	Substantially Equivalent	Healthtek, Inc.
K860803	IV FILTER EXTENSION SET	Apr 09, 1986	Substantially Equivalent	Med Fusion Systems, Inc.
K860746	AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER	Apr 07, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K855065	PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE	Feb 28, 1986	Substantially Equivalent	Cobe Laboratories, Inc.
K854172	I.V. WATCH	Dec 05, 1985	Substantially Equivalent	Alltek, Inc.
K852996	DYNA GARD SYRINGE FILTER	Sep 19, 1985	Substantially Equivalent	Microgon, Inc.
K851818	SARTORIUS MINI SART FH 16592	Aug 19, 1985	Substantially Equivalent	Sartorius Filters, Inc.
K851817	SARTORIUS MINI-SART FH 16555	Aug 19, 1985	Substantially Equivalent	Sartorius Filters, Inc.
K851816	SARTORIUS MINISART FH 16534	Aug 19, 1985	Substantially Equivalent	Sartorius Filters, Inc.
K852030	PEDIATRIC IV WATCH	May 30, 1985	Substantially Equivalent	Alltek, Inc.
K852029	I.V. WATCH	May 30, 1985	Substantially Equivalent	Alltek, Inc.
K850826	POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96	Apr 09, 1985	Substantially Equivalent	Pall Biomedical Products Co.
K850825	AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR	Apr 09, 1985	Substantially Equivalent	Pall Biomedical Products Co.
K842399	48 HOUR SET CHANGES	Oct 09, 1984	Substantially Equivalent	Tri-Med, Inc.
K842075	CRITIKON I.V. FILTER	Jun 28, 1984	Substantially Equivalent	Critikon Company, LLC
K841280	SOLOPAK BRAND FILTER NEEDLE W/5 MICRO	May 21, 1984	Substantially Equivalent	Smith & Nephew, Mpl Division
K834376	FILTRARE TM ALLVENT TM	May 11, 1984	Substantially Equivalent	Alltek, Inc.
K834381	POSIDYNE I.V. FILTER/AIR ELIMINATOR	Apr 24, 1984	Substantially Equivalent	Pall Biomedical Products Co.
K840248	IV-FILTER	Apr 20, 1984	Substantially Equivalent	Tri-Med, Inc.
K833684	IVEX-INT	Dec 27, 1983	Substantially Equivalent	Abbott Laboratories
K832952	MILLIPORE IVEX INT FILTER UNIT	Oct 04, 1983	Substantially Equivalent	Millipore Corp.
K831882	POSIDYNE SOLUTION CONTAINER FILTER	Sep 20, 1983	Substantially Equivalent	Pall Biomedical Products Co.
K831668	CONTINU-FLO SOLUTION ADMINISTRATION	Aug 16, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K831350	IVFLO-HP & IVFIL-HP FILTER	Aug 12, 1983	Substantially Equivalent	Tri-Med, Inc.
K831315	TRILEX	Aug 12, 1983	Substantially Equivalent	Tri-Med, Inc.
K823690	IVFLO-HP & IVFIL-HP	Dec 28, 1982	Substantially Equivalent	Tri-Med, Inc.
K821013	IVEX-HP PEDIATRIC EXTENSION SET-SL	Jul 30, 1982	Substantially Equivalent	Abbott Laboratories
K813454	I.V. FILTER-PREVENT	Jan 05, 1982	Substantially Equivalent	Pioneer Viggo, Inc.
K813446	IV FILTERSET 0.22 MICROMETER	Jan 05, 1982	Substantially Equivalent	Imed Corp.
K813445	IV FILTERSET 5 MICROMETER	Jan 05, 1982	Substantially Equivalent	Imed Corp.
K813001	FIBRI-FILTER 20	Nov 06, 1981	Substantially Equivalent	Tri-Med, Inc.
K812457	HIFLO-HP	Sep 21, 1981	Substantially Equivalent	Tri-Med, Inc.
K811773	BACTAGARD	Jul 13, 1981	Substantially Equivalent	Tri-Med, Inc.
K810113	TERFUSION FINAL FILTER SET	Mar 27, 1981	Substantially Equivalent	Terumo Medical Corp.
K802765	ACRODISC FILTER ASSEMBLY	Jan 21, 1981	Substantially Equivalent	Gelman Sciences, Inc.
K801602	DESERET I.V. FILTER	Aug 27, 1980	Substantially Equivalent	Hospital Products Co.
K801614	MODEL 40-30-2 AIR ELIMINATING FILTER SET	Aug 13, 1980	Substantially Equivalent	Y
K801605	BIMECO FILTERED EXTENSION SET	Aug 12, 1980	Substantially Equivalent	Burron Medical Products, Inc.
K801343	B-D FILTER NEEDLE	Jun 20, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K792510	MICROBAR MONITORING LINE FILTER	Dec 20, 1979	Substantially Equivalent	Medex, Inc.
K791822	BIOGUARD INFUSION LINE FILTER	Nov 13, 1979	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K792021	LARGE VOLUME 5 MICRON CONICAL FILTER	Oct 26, 1979	Substantially Equivalent	National Patent Development Corp.
K791809	BLOOD TRANSFUSION MICROFILTER	Oct 26, 1979	Substantially Equivalent	Pioneer Viggo, Inc.
K790879	ULTIPOR SOLUTION CONTAINER FILTER	Jun 01, 1979	Substantially Equivalent	Pall Biomedical Products Co.
K790471	JELCO* DISC FILTER-0.2 MICRON	Apr 30, 1979	Substantially Equivalent	Jelco Laboratories
K790314	FLUID ADMINISTRATION SETS, 15 MICRON	Mar 06, 1979	Substantially Equivalent	Medex, Inc.
K781815	HEMO-NATE SYRINGE BLOOD FILTER	Feb 27, 1979	Substantially Equivalent	Gisco Intl.
K772312	FILTERSET W/Y-INJECTION SITE, 0.2	Jan 26, 1978	Substantially Equivalent	Abbott Laboratories
K771972	5UM FILTERSET WITH Y-INJECTION SITE	Jan 03, 1978	Substantially Equivalent	Abbott Laboratories
K771536	AIR VENT FILTER NEEDLE, 0.45	Oct 25, 1977	Substantially Equivalent	Jelco Laboratories
K771862	TRANSFUSION BLOOD FILTER	Oct 13, 1977	Substantially Equivalent	Medical, Inc.
K771827	INTRAVENOUS FILTER W/FLASH BULB	Oct 13, 1977	Substantially Equivalent	Jelco Laboratories
K771826	INTRAVENOUS FILTER W/AUTO AIR VENT	Oct 13, 1977	Substantially Equivalent	Jelco Laboratories
K771594	PRIMARY PIGGYBACK VENOSET W/ FILTER	Sep 28, 1977	Substantially Equivalent	Abbott Laboratories
K771430	BLOOD FILTER, W/SET	Sep 20, 1977	Substantially Equivalent	Terumo America, Inc.
K771498	CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET	Aug 19, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K770843	IV PUMP FILTERSET, UNIVERSAL	Jun 14, 1977	Substantially Equivalent	Abbott Laboratories
K770703	FILTER UNIT, SINGLE USE	Jun 14, 1977	Substantially Equivalent	Millipore Corp.
K770182	0.22/UM FILTERSET W/Y-INJECTION SITE	Mar 15, 1977	Substantially Equivalent	Abbott Laboratories
K770183	O.22/UM FILTERSET W/FLASHBACK	Feb 09, 1977	Substantially Equivalent	Abbott Laboratories