FPB · Class II · 21 CFR 880.5440

FDA Product Code FPB: Filter, Infusion Line

Leading manufacturers include Abbott Laboratories, Travenol Laboratories, S.A. and Baxter Healthcare Corp.

98
Total
98
Cleared
94d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Filter, Infusion Line Devices (Product Code FPB)

98 devices
1–24 of 98
Cleared May 10, 2024
Filter Needle for Single Use
K233277
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
General Hospital · 224d
Cleared Dec 08, 2011
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227
Baxter Healthcare Corp
General Hospital · 37d
Cleared Feb 11, 1998
0.2 U BACTERIAL FILTER
K974661
Sims Deltec, Inc.
General Hospital · 58d
Cleared Sep 29, 1994
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127
Gelman Sciences, Inc.
General Hospital · 92d
Cleared Aug 03, 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684
Abbott Laboratories
General Hospital · 121d
Cleared Jul 26, 1994
VIAL VENT FILTER
K942275
Gelman Sciences, Inc.
General Hospital · 77d
Cleared Apr 26, 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869
Baxter Healthcare Corp
General Hospital · 260d
Cleared Feb 09, 1994
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
K933294
Aesculap, Inc.
General Hospital · 217d
Cleared Nov 10, 1993
FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
K932301
Baxter Healthcare Corp
General Hospital · 182d
Cleared Sep 21, 1993
FENWAL 40 MICRON TRANSFUSION FILTER
K931441
Baxter Healthcare Corp
General Hospital · 183d
Cleared Apr 23, 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736
Abbott Laboratories
General Hospital · 429d
Cleared Jan 15, 1992
IVEX-TPN EXTENSION FILTER SET
K913308
Abbott Laboratories
General Hospital · 174d
Cleared May 26, 1988
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605
Miles Laboratories, Inc.
General Hospital · 104d
Cleared Apr 14, 1988
CHURCHILL 0.22 MICRON LIQUID FILTER SETS
K880025
Churchill Corp.
General Hospital · 100d
Cleared Apr 14, 1988
CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS
K880026
Churchill Corp.
General Hospital · 100d
Cleared Apr 13, 1988
CHURCHILL 1.2 MICRON LIQUID FILTER SET
K880027
Churchill Corp.
General Hospital · 99d
Cleared Aug 04, 1987
CUTTER PUREFLO PLUS IV FILTER
K872634
Miles Laboratories, Inc.
General Hospital · 29d
Cleared Apr 17, 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029
Travenol Laboratories, S.A.
General Hospital · 115d
Cleared Jul 22, 1986
CRITIKON 48-HOUR AIR ELIMINATING FILTER
K861644
Critikon Company, LLC
General Hospital · 83d
Cleared Apr 07, 1986
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746
Travenol Laboratories, S.A.
General Hospital · 39d
Cleared Feb 28, 1986
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
K855065
Cobe Laboratories, Inc.
General Hospital · 72d
Cleared Jun 28, 1984
CRITIKON I.V. FILTER
K842075
Critikon Company, LLC
General Hospital · 36d
Cleared Dec 27, 1983
IVEX-INT
K833684
Abbott Laboratories
General Hospital · 57d
Cleared Aug 16, 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668
Travenol Laboratories, S.A.
General Hospital · 85d

About Product Code FPB - Regulatory Context

510(k) Submission Activity

98 total 510(k) submissions under product code FPB since 1977, with 98 receiving FDA clearance (average review time: 94 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.