Atlas FDA

FPB

98 FDA 510(k) clearances · Product code

70 daysmedian time to decision
182 days90th percentile
98clearances measured

FDA profile

Official device name
Filter, Infusion Line
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 160 · 2022: 36 · 2023: 39 · 2024: 47 · 2025: 34 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Filter Needle for Single Use (K233277)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-10
Cathivex ¿GV filter units (K143583)Merck Millipore , Ltd.2015-08-11
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (K113227)Baxter Healthcare Corp2011-12-08
ARTERIA BLOOD FILTER (K021293)Arteria Medical Science, Inc.2002-08-22
PALL SUPOR AEF FILTER (K993379)Pall Corp.1999-12-16
0.2 U BACTERIAL FILTER (K974661)Sims Deltec, Inc.1998-02-11
AUTOPRIME (K964283)Arbor Technologies, Inc.1997-01-22
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (K954331)Pall Biomedical Products Co.1997-01-09
I.V. FILTER SET (K933523)Mediziv Medical Products 1987 , Ltd.1995-05-19
40 MICRON BLOOD TRANSFUSION FILTER (K941628)Douglas Medical Products Corp.1995-02-16
1.2 MICRON AIR ELIMINATING FILTER (K942625)The Medi-Dose Group1994-10-07
PHARMASSURE LARGE VOLUME TRANSFER FILTERS (K943127)Gelman Sciences, Inc.1994-09-29
2 MICRON AIR ELIMINATING FILTER (K942532)Medi-Dose, Inc.1994-08-17
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (K941684)Abbott Laboratories1994-08-03
VIAL VENT FILTER (K942275)Gelman Sciences, Inc.1994-07-26
CHARGED SUPOR(R) FILTER EXTENSION SET (K940980)B. Braun of America, Inc.1994-07-14
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER (K933869)Baxter Healthcare Corp1994-04-26
1.2 MICRON FINAL FILTER WITH EXTENSION TUBE (K940293)Puritas Health Care, Inc.1994-03-28
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES (K933294)Aesculap, Inc.1994-02-09
0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS (K935641)Evans Medical, Inc.1994-01-28
FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER (K932301)Baxter Healthcare Corp1993-11-10
FENWAL 40 MICRON TRANSFUSION FILTER (K931441)Baxter Healthcare Corp1993-09-21
IVEX-HP96 EXTENDED LIFE FILTER SET (K920736)Abbott Laboratories1993-04-23
IVEX-TPN EXTENSION FILTER SET (K913308)Abbott Laboratories1992-01-15
I.V. FILTER EXTENSION SET (K912848)Filtertek, Inc.1991-11-29
PALL 3N1 FILTER (K905794)Pall Biomedical Products Co.1991-06-13
I.V. EXTENDER SET (K911451)Filtertek, Inc.1991-06-06
CMS IV FILTERS (K896333)Churchill Medical Systems, Inc.1990-01-11
1.2 MICRON FILTER WITH IV SET (K896292)Kendall Mcgaw Laboratories, Inc.1989-12-08
.22 & 1.2 MICRON IV FILTERS (K894954)Churchill Medical Systems, Inc.1989-11-13
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (K880605)Miles Laboratories, Inc.1988-05-26
CHURCHILL 0.22 MICRON LIQUID FILTER SETS (K880025)Churchill Corp.1988-04-14
CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS (K880026)Churchill Corp.1988-04-14
CHURCHILL 1.2 MICRON LIQUID FILTER SET (K880027)Churchill Corp.1988-04-13
CUTTER PUREFLO PLUS IV FILTER (K872634)Miles Laboratories, Inc.1987-08-04
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (K865029)Travenol Laboratories, S.A.1987-04-17
CLYDE (TM) FILTRATION SYSTEM (K864113)Arbor Technologies, Inc.1987-02-04
CRITIKON 48-HOUR AIR ELIMINATING FILTER (K861644)Critikon Company, LLC1986-07-22
FAST FLOW XX (AQUEOUS SOLUTION FILTER) (K860372)Healthtek, Inc.1986-05-30
IV FILTER EXTENSION SET (K860803)Med Fusion Systems, Inc.1986-04-09
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER (K860746)Travenol Laboratories, S.A.1986-04-07
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE (K855065)Cobe Laboratories, Inc.1986-02-28
I.V. WATCH (K854172)Alltek, Inc.1985-12-05
DYNA GARD SYRINGE FILTER (K852996)Microgon, Inc.1985-09-19
SARTORIUS MINI SART FH 16592 (K851818)Sartorius Filters, Inc.1985-08-19
SARTORIUS MINI-SART FH 16555 (K851817)Sartorius Filters, Inc.1985-08-19
SARTORIUS MINISART FH 16534 (K851816)Sartorius Filters, Inc.1985-08-19
PEDIATRIC IV WATCH (K852030)Alltek, Inc.1985-05-30
I.V. WATCH (K852029)Alltek, Inc.1985-05-30
AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR (K850825)Pall Biomedical Products Co.1985-04-09
POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 (K850826)Pall Biomedical Products Co.1985-04-09
48 HOUR SET CHANGES (K842399)Tri-Med, Inc.1984-10-09
CRITIKON I.V. FILTER (K842075)Critikon Company, LLC1984-06-28
SOLOPAK BRAND FILTER NEEDLE W/5 MICRO (K841280)Smith & Nephew, Mpl Division1984-05-21
FILTRARE TM ALLVENT TM (K834376)Alltek, Inc.1984-05-11
POSIDYNE I.V. FILTER/AIR ELIMINATOR (K834381)Pall Biomedical Products Co.1984-04-24
IV-FILTER (K840248)Tri-Med, Inc.1984-04-20
IVEX-INT (K833684)Abbott Laboratories1983-12-27
MILLIPORE IVEX INT FILTER UNIT (K832952)Millipore Corp.1983-10-04
POSIDYNE SOLUTION CONTAINER FILTER (K831882)Pall Biomedical Products Co.1983-09-20
CONTINU-FLO SOLUTION ADMINISTRATION (K831668)Travenol Laboratories, S.A.1983-08-16
TRILEX (K831315)Tri-Med, Inc.1983-08-12
IVFLO-HP & IVFIL-HP FILTER (K831350)Tri-Med, Inc.1983-08-12
IVFLO-HP & IVFIL-HP (K823690)Tri-Med, Inc.1982-12-28
IVEX-HP PEDIATRIC EXTENSION SET-SL (K821013)Abbott Laboratories1982-07-30
IV FILTERSET 0.22 MICROMETER (K813446)Imed Corp.1982-01-05
I.V. FILTER-PREVENT (K813454)Pioneer Viggo, Inc.1982-01-05
IV FILTERSET 5 MICROMETER (K813445)Imed Corp.1982-01-05
FIBRI-FILTER 20 (K813001)Tri-Med, Inc.1981-11-06
HIFLO-HP (K812457)Tri-Med, Inc.1981-09-21
BACTAGARD (K811773)Tri-Med, Inc.1981-07-13
TERFUSION FINAL FILTER SET (K810113)Terumo Medical Corp.1981-03-27
ACRODISC FILTER ASSEMBLY (K802765)Gelman Sciences, Inc.1981-01-21
DESERET I.V. FILTER (K801602)Hospital Products Co.1980-08-27
MODEL 40-30-2 AIR ELIMINATING FILTER SET (K801614)Y1980-08-13
BIMECO FILTERED EXTENSION SET (K801605)Burron Medical Products, Inc.1980-08-12
B-D FILTER NEEDLE (K801343)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-06-20
MICROBAR MONITORING LINE FILTER (K792510)Medex, Inc.1979-12-20
BIOGUARD INFUSION LINE FILTER (K791822)United States Surgical, A Division of Tyco Healthc1979-11-13
BLOOD TRANSFUSION MICROFILTER (K791809)Pioneer Viggo, Inc.1979-10-26
LARGE VOLUME 5 MICRON CONICAL FILTER (K792021)National Patent Development Corp.1979-10-26
ULTIPOR SOLUTION CONTAINER FILTER (K790879)Pall Biomedical Products Co.1979-06-01
JELCO* DISC FILTER-0.2 MICRON (K790471)Jelco Laboratories1979-04-30
FLUID ADMINISTRATION SETS, 15 MICRON (K790314)Medex, Inc.1979-03-06
HEMO-NATE SYRINGE BLOOD FILTER (K781815)Gisco Intl.1979-02-27
FILTERSET W/Y-INJECTION SITE, 0.2 (K772312)Abbott Laboratories1978-01-26
5UM FILTERSET WITH Y-INJECTION SITE (K771972)Abbott Laboratories1978-01-03
AIR VENT FILTER NEEDLE, 0.45 (K771536)Jelco Laboratories1977-10-25
TRANSFUSION BLOOD FILTER (K771862)Medical, Inc.1977-10-13
INTRAVENOUS FILTER W/FLASH BULB (K771827)Jelco Laboratories1977-10-13
INTRAVENOUS FILTER W/AUTO AIR VENT (K771826)Jelco Laboratories1977-10-13
PRIMARY PIGGYBACK VENOSET W/ FILTER (K771594)Abbott Laboratories1977-09-28
BLOOD FILTER, W/SET (K771430)Terumo America, Inc.1977-09-20
CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET (K771498)Travenol Laboratories, S.A.1977-08-19
IV PUMP FILTERSET, UNIVERSAL (K770843)Abbott Laboratories1977-06-14
FILTER UNIT, SINGLE USE (K770703)Millipore Corp.1977-06-14
0.22/UM FILTERSET W/Y-INJECTION SITE (K770182)Abbott Laboratories1977-03-15
O.22/UM FILTERSET W/FLASHBACK (K770183)Abbott Laboratories1977-02-09

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Every clearance here is in the API, with alerts when new ones post.