FPB · Class II · 21 CFR 880.5440

FDA Product Code FPB: Filter, Infusion Line

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

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 Aug 03, 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684
Abbott Laboratories
General Hospital · 121d
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 Apr 17, 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029
Travenol Laboratories, S.A.
General Hospital · 115d
Cleared Apr 07, 1986
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746
Travenol Laboratories, S.A.
General Hospital · 39d
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
Cleared Jul 30, 1982
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013
Abbott Laboratories
General Hospital · 109d
Cleared Jun 20, 1980
B-D FILTER NEEDLE
K801343
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 15d
Cleared Nov 13, 1979
BIOGUARD INFUSION LINE FILTER
K791822
United States Surgical, A Division of Tyco Healthc
General Hospital · 60d
Cleared Jan 26, 1978
FILTERSET W/Y-INJECTION SITE, 0.2
K772312
Abbott Laboratories
General Hospital · 41d
Cleared Jan 03, 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972
Abbott Laboratories
General Hospital · 78d
Cleared Sep 28, 1977
PRIMARY PIGGYBACK VENOSET W/ FILTER
K771594
Abbott Laboratories
General Hospital · 40d
Cleared Aug 19, 1977
CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET
K771498
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Jun 14, 1977
IV PUMP FILTERSET, UNIVERSAL
K770843
Abbott Laboratories
General Hospital · 36d
Cleared Mar 15, 1977
0.22/UM FILTERSET W/Y-INJECTION SITE
K770182
Abbott Laboratories
General Hospital · 47d
Cleared Feb 09, 1977
O.22/UM FILTERSET W/FLASHBACK
K770183
Abbott Laboratories
General Hospital · 13d

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.