Product code FPB— General Hospital
I.V. WATCH
- Classification name
- Filter, Infusion Line
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Total cleared
- 99
- First cleared
- Most recent
Market context for product code FPB
FDA has cleared devices under product code FPB between 1977 and 2026, filed by 49 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2015
- 2011
- 2002
- 1999
- 1998
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
Top applicants under product code FPB
Adverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FPB
- K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
- K233277 — Filter Needle for Single Use
- K143583 — Cathivex ¿GV filter units
- K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
- K021293 — ARTERIA BLOOD FILTER
- K993379 — PALL SUPOR AEF FILTER
- K974661 — 0.2 U BACTERIAL FILTER
- K964283 — AUTOPRIME
- K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
- K933523 — I.V. FILTER SET
- K941628 — 40 MICRON BLOOD TRANSFUSION FILTER
- K942625 — 1.2 MICRON AIR ELIMINATING FILTER
- K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS
- K942532 — 2 MICRON AIR ELIMINATING FILTER
- K941684 — IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
- K942275 — VIAL VENT FILTER
- K940980 — CHARGED SUPOR(R) FILTER EXTENSION SET
- K933869 — EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
- K940293 — 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
- K933294 — MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
- K935641 — 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS
- K932301 — FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
- K931441 — FENWAL 40 MICRON TRANSFUSION FILTER
- K920736 — IVEX-HP96 EXTENDED LIFE FILTER SET
- K913308 — IVEX-TPN EXTENSION FILTER SET
- K912848 — I.V. FILTER EXTENSION SET
- K905794 — PALL 3N1 FILTER
- K911451 — I.V. EXTENDER SET
- K896333 — CMS IV FILTERS
- K896292 — 1.2 MICRON FILTER WITH IV SET
- K894954 — .22 & 1.2 MICRON IV FILTERS
- K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
- K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS
- K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS
- K880027 — CHURCHILL 1.2 MICRON LIQUID FILTER SET
- K872634 — CUTTER PUREFLO PLUS IV FILTER
- K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
- K864113 — CLYDE (TM) FILTRATION SYSTEM
- K861644 — CRITIKON 48-HOUR AIR ELIMINATING FILTER
- K860372 — FAST FLOW XX (AQUEOUS SOLUTION FILTER)
- K860803 — IV FILTER EXTENSION SET
- K860746 — AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
- K855065 — PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
- K854172 — I.V. WATCH
- K852996 — DYNA GARD SYRINGE FILTER
- K851816 — SARTORIUS MINISART FH 16534
- K851817 — SARTORIUS MINI-SART FH 16555
- K851818 — SARTORIUS MINI SART FH 16592
- K852029 — I.V. WATCH
- K852030 — PEDIATRIC IV WATCH
- K850825 — AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR
- K850826 — POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96
- K842399 — 48 HOUR SET CHANGES
- K842075 — CRITIKON I.V. FILTER
- K841280 — SOLOPAK BRAND FILTER NEEDLE W/5 MICRO
- K834376 — FILTRARE TM ALLVENT TM
- K834381 — POSIDYNE I.V. FILTER/AIR ELIMINATOR
- K840248 — IV-FILTER
- K833684 — IVEX-INT
- K832952 — MILLIPORE IVEX INT FILTER UNIT
- K831882 — POSIDYNE SOLUTION CONTAINER FILTER
- K831668 — CONTINU-FLO SOLUTION ADMINISTRATION
- K831315 — TRILEX
- K831350 — IVFLO-HP & IVFIL-HP FILTER
- K823690 — IVFLO-HP & IVFIL-HP
- K821013 — IVEX-HP PEDIATRIC EXTENSION SET-SL
- K813445 — IV FILTERSET 5 MICROMETER
- K813446 — IV FILTERSET 0.22 MICROMETER
- K813454 — I.V. FILTER-PREVENT
- K813001 — FIBRI-FILTER 20
- K812457 — HIFLO-HP
- K811773 — BACTAGARD
- K810113 — TERFUSION FINAL FILTER SET
- K802765 — ACRODISC FILTER ASSEMBLY
- K801602 — DESERET I.V. FILTER
- K801614 — MODEL 40-30-2 AIR ELIMINATING FILTER SET
- K801605 — BIMECO FILTERED EXTENSION SET
- K801343 — B-D FILTER NEEDLE
- K792510 — MICROBAR MONITORING LINE FILTER
- K791822 — BIOGUARD INFUSION LINE FILTER
- K791809 — BLOOD TRANSFUSION MICROFILTER
- K792021 — LARGE VOLUME 5 MICRON CONICAL FILTER
- K790879 — ULTIPOR SOLUTION CONTAINER FILTER
- K790471 — JELCO* DISC FILTER-0.2 MICRON
- K790314 — FLUID ADMINISTRATION SETS, 15 MICRON
- K781815 — HEMO-NATE SYRINGE BLOOD FILTER
- K772312 — FILTERSET W/Y-INJECTION SITE, 0.2
- K771972 — 5UM FILTERSET WITH Y-INJECTION SITE
- K771536 — AIR VENT FILTER NEEDLE, 0.45
- K771826 — INTRAVENOUS FILTER W/AUTO AIR VENT
- K771827 — INTRAVENOUS FILTER W/FLASH BULB
- K771862 — TRANSFUSION BLOOD FILTER
- K771594 — PRIMARY PIGGYBACK VENOSET W/ FILTER
- K771430 — BLOOD FILTER, W/SET
- K771498 — CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET
- K770703 — FILTER UNIT, SINGLE USE
- K770843 — IV PUMP FILTERSET, UNIVERSAL
- K770182 — 0.22/UM FILTERSET W/Y-INJECTION SITE
- K770183 — O.22/UM FILTERSET W/FLASHBACK
Data sourced from openFDA. This site is unofficial and independent of the FDA.