FDA Product Code
FDA Product Code FPB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 99 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | 2026-08-31 | Traditional | PDF ↗ |
| K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K143583 | Cathivex ¿GV filter units | Merck Millipore , Ltd. | 2015-08-11 | Traditional | PDF ↗ |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Baxter Healthcare Corp | 2011-12-08 | Special | PDF ↗ |
| K021293 | ARTERIA BLOOD FILTER | Arteria Medical Science, Inc. | 2002-08-22 | Traditional | PDF ↗ |
| K993379 | PALL SUPOR AEF FILTER | Pall Corp. | 1999-12-16 | Traditional | PDF ↗ |
| K974661 | 0.2 U BACTERIAL FILTER | Sims Deltec, Inc. | 1998-02-11 | Traditional | PDF ↗ |
| K964283 | AUTOPRIME | Arbor Technologies, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Pall Biomedical Products Co. | 1997-01-09 | Traditional | PDF ↗ |
| K933523 | I.V. FILTER SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-19 | Traditional | PDF ↗ |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | Douglas Medical Products Corp. | 1995-02-16 | Traditional | PDF ↗ |
| K942625 | 1.2 MICRON AIR ELIMINATING FILTER | The Medi-Dose Group | 1994-10-07 | Traditional | PDF ↗ |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Gelman Sciences, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K942532 | 2 MICRON AIR ELIMINATING FILTER | Medi-Dose, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K941684 | IVEX-2 EXTENSION SET WITH Y-INJECTION SITE | Abbott Laboratories | 1994-08-03 | Traditional | PDF ↗ |
| K942275 | VIAL VENT FILTER | Gelman Sciences, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET | B. Braun of America, Inc. | 1994-07-14 | Traditional | PDF ↗ |
| K933869 | EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER | Baxter Healthcare Corp | 1994-04-26 | Traditional | PDF ↗ |
| K940293 | 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE | Puritas Health Care, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K933294 | MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES | Aesculap, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K935641 | 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS | Evans Medical, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K932301 | FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER | Baxter Healthcare Corp | 1993-11-10 | Traditional | PDF ↗ |
| K931441 | FENWAL 40 MICRON TRANSFUSION FILTER | Baxter Healthcare Corp | 1993-09-21 | Traditional | PDF ↗ |
| K920736 | IVEX-HP96 EXTENDED LIFE FILTER SET | Abbott Laboratories | 1993-04-23 | Traditional | PDF ↗ |
| K913308 | IVEX-TPN EXTENSION FILTER SET | Abbott Laboratories | 1992-01-15 | Traditional | PDF ↗ |
| K912848 | I.V. FILTER EXTENSION SET | Filtertek, Inc. | 1991-11-29 | Traditional | PDF ↗ |
| K905794 | PALL 3N1 FILTER | Pall Biomedical Products Co. | 1991-06-13 | Traditional | PDF ↗ |
| K911451 | I.V. EXTENDER SET | Filtertek, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K896333 | CMS IV FILTERS | Churchill Medical Systems, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K896292 | 1.2 MICRON FILTER WITH IV SET | Kendall Mcgaw Laboratories, Inc. | 1989-12-08 | Traditional | PDF ↗ |
| K894954 | .22 & 1.2 MICRON IV FILTERS | Churchill Medical Systems, Inc. | 1989-11-13 | Traditional | PDF ↗ |
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | Miles Laboratories, Inc. | 1988-05-26 | Traditional | PDF ↗ |
| K880025 | CHURCHILL 0.22 MICRON LIQUID FILTER SETS | Churchill Corp. | 1988-04-14 | Traditional | PDF ↗ |
| K880026 | CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS | Churchill Corp. | 1988-04-14 | Traditional | PDF ↗ |
| K880027 | CHURCHILL 1.2 MICRON LIQUID FILTER SET | Churchill Corp. | 1988-04-13 | Traditional | PDF ↗ |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | Miles Laboratories, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Travenol Laboratories, S.A. | 1987-04-17 | Traditional | PDF ↗ |
| K864113 | CLYDE (TM) FILTRATION SYSTEM | Arbor Technologies, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K861644 | CRITIKON 48-HOUR AIR ELIMINATING FILTER | Critikon Company, LLC | 1986-07-22 | Traditional | PDF ↗ |
| K860372 | FAST FLOW XX (AQUEOUS SOLUTION FILTER) | Healthtek, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K860803 | IV FILTER EXTENSION SET | Med Fusion Systems, Inc. | 1986-04-09 | Traditional | PDF ↗ |
| K860746 | AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER | Travenol Laboratories, S.A. | 1986-04-07 | Traditional | PDF ↗ |
| K855065 | PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE | Cobe Laboratories, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K854172 | I.V. WATCH | Alltek, Inc. | 1985-12-05 | Traditional | PDF ↗ |
| K852996 | DYNA GARD SYRINGE FILTER | Microgon, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K851818 | SARTORIUS MINI SART FH 16592 | Sartorius Filters, Inc. | 1985-08-19 | Traditional | PDF ↗ |
| K851816 | SARTORIUS MINISART FH 16534 | Sartorius Filters, Inc. | 1985-08-19 | Traditional | PDF ↗ |
| K851817 | SARTORIUS MINI-SART FH 16555 | Sartorius Filters, Inc. | 1985-08-19 | Traditional | PDF ↗ |
| K852030 | PEDIATRIC IV WATCH | Alltek, Inc. | 1985-05-30 | Traditional | PDF ↗ |
| K852029 | I.V. WATCH | Alltek, Inc. | 1985-05-30 | Traditional | PDF ↗ |
| K850825 | AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR | Pall Biomedical Products Co. | 1985-04-09 | Traditional | PDF ↗ |
| K850826 | POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 | Pall Biomedical Products Co. | 1985-04-09 | Traditional | PDF ↗ |
| K842399 | 48 HOUR SET CHANGES | Tri-Med, Inc. | 1984-10-09 | Traditional | PDF ↗ |
| K842075 | CRITIKON I.V. FILTER | Critikon Company, LLC | 1984-06-28 | Traditional | PDF ↗ |
| K841280 | SOLOPAK BRAND FILTER NEEDLE W/5 MICRO | Smith & Nephew, Mpl Division | 1984-05-21 | Traditional | PDF ↗ |
| K834376 | FILTRARE TM ALLVENT TM | Alltek, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K834381 | POSIDYNE I.V. FILTER/AIR ELIMINATOR | Pall Biomedical Products Co. | 1984-04-24 | Traditional | PDF ↗ |
| K840248 | IV-FILTER | Tri-Med, Inc. | 1984-04-20 | Traditional | PDF ↗ |
| K833684 | IVEX-INT | Abbott Laboratories | 1983-12-27 | Traditional | PDF ↗ |
| K832952 | MILLIPORE IVEX INT FILTER UNIT | Millipore Corp. | 1983-10-04 | Traditional | PDF ↗ |
| K831882 | POSIDYNE SOLUTION CONTAINER FILTER | Pall Biomedical Products Co. | 1983-09-20 | Traditional | PDF ↗ |
| K831668 | CONTINU-FLO SOLUTION ADMINISTRATION | Travenol Laboratories, S.A. | 1983-08-16 | Traditional | PDF ↗ |
| K831350 | IVFLO-HP & IVFIL-HP FILTER | Tri-Med, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831315 | TRILEX | Tri-Med, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K823690 | IVFLO-HP & IVFIL-HP | Tri-Med, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K821013 | IVEX-HP PEDIATRIC EXTENSION SET-SL | Abbott Laboratories | 1982-07-30 | Traditional | PDF ↗ |
| K813454 | I.V. FILTER-PREVENT | Pioneer Viggo, Inc. | 1982-01-05 | Traditional | PDF ↗ |
| K813445 | IV FILTERSET 5 MICROMETER | Imed Corp. | 1982-01-05 | Traditional | PDF ↗ |
| K813446 | IV FILTERSET 0.22 MICROMETER | Imed Corp. | 1982-01-05 | Traditional | PDF ↗ |
| K813001 | FIBRI-FILTER 20 | Tri-Med, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812457 | HIFLO-HP | Tri-Med, Inc. | 1981-09-21 | Traditional | PDF ↗ |
| K811773 | BACTAGARD | Tri-Med, Inc. | 1981-07-13 | Traditional | PDF ↗ |
| K810113 | TERFUSION FINAL FILTER SET | Terumo Medical Corp. | 1981-03-27 | Traditional | PDF ↗ |
| K802765 | ACRODISC FILTER ASSEMBLY | Gelman Sciences, Inc. | 1981-01-21 | Traditional | PDF ↗ |
| K801602 | DESERET I.V. FILTER | Hospital Products Co. | 1980-08-27 | Traditional | PDF ↗ |
| K801614 | MODEL 40-30-2 AIR ELIMINATING FILTER SET | Y | 1980-08-13 | Traditional | PDF ↗ |
| K801605 | BIMECO FILTERED EXTENSION SET | Burron Medical Products, Inc. | 1980-08-12 | Traditional | PDF ↗ |
| K801343 | B-D FILTER NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-06-20 | Traditional | PDF ↗ |
| K792510 | MICROBAR MONITORING LINE FILTER | Medex, Inc. | 1979-12-20 | Traditional | PDF ↗ |
| K791822 | BIOGUARD INFUSION LINE FILTER | United States Surgical, A Division of Tyco Healthc | 1979-11-13 | Traditional | PDF ↗ |
| K791809 | BLOOD TRANSFUSION MICROFILTER | Pioneer Viggo, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K792021 | LARGE VOLUME 5 MICRON CONICAL FILTER | National Patent Development Corp. | 1979-10-26 | Traditional | PDF ↗ |
| K790879 | ULTIPOR SOLUTION CONTAINER FILTER | Pall Biomedical Products Co. | 1979-06-01 | Traditional | PDF ↗ |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | Jelco Laboratories | 1979-04-30 | Traditional | PDF ↗ |
| K790314 | FLUID ADMINISTRATION SETS, 15 MICRON | Medex, Inc. | 1979-03-06 | Traditional | PDF ↗ |
| K781815 | HEMO-NATE SYRINGE BLOOD FILTER | Gisco Intl. | 1979-02-27 | Traditional | PDF ↗ |
| K772312 | FILTERSET W/Y-INJECTION SITE, 0.2 | Abbott Laboratories | 1978-01-26 | Traditional | PDF ↗ |
| K771972 | 5UM FILTERSET WITH Y-INJECTION SITE | Abbott Laboratories | 1978-01-03 | Traditional | PDF ↗ |
| K771536 | AIR VENT FILTER NEEDLE, 0.45 | Jelco Laboratories | 1977-10-25 | Traditional | PDF ↗ |
| K771862 | TRANSFUSION BLOOD FILTER | Medical, Inc. | 1977-10-13 | Traditional | PDF ↗ |
| K771827 | INTRAVENOUS FILTER W/FLASH BULB | Jelco Laboratories | 1977-10-13 | Traditional | PDF ↗ |
| K771826 | INTRAVENOUS FILTER W/AUTO AIR VENT | Jelco Laboratories | 1977-10-13 | Traditional | PDF ↗ |
| K771594 | PRIMARY PIGGYBACK VENOSET W/ FILTER | Abbott Laboratories | 1977-09-28 | Traditional | PDF ↗ |
| K771430 | BLOOD FILTER, W/SET | Terumo America, Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K771498 | CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET | Travenol Laboratories, S.A. | 1977-08-19 | Traditional | PDF ↗ |
| K770843 | IV PUMP FILTERSET, UNIVERSAL | Abbott Laboratories | 1977-06-14 | Traditional | PDF ↗ |
| K770703 | FILTER UNIT, SINGLE USE | Millipore Corp. | 1977-06-14 | Traditional | PDF ↗ |
| K770182 | 0.22/UM FILTERSET W/Y-INJECTION SITE | Abbott Laboratories | 1977-03-15 | Traditional | PDF ↗ |
| K770183 | O.22/UM FILTERSET W/FLASHBACK | Abbott Laboratories | 1977-02-09 | Traditional | PDF ↗ |
Product code FPB · Class II · General Hospital. Data: openFDA.