FPB · Class II · 21 CFR 880.5440

FDA Product Code FPB: Filter, Infusion Line

Leading manufacturers include Abbott Laboratories, Tri-Med, Inc. and Pall Biomedical Products Co..

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 Aug 11, 2015
Cathivex ¿GV filter units
K143583
Merck Millipore , Ltd.
General Hospital · 236d
Cleared Dec 08, 2011
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227
Baxter Healthcare Corp
General Hospital · 37d
Cleared Aug 22, 2002
ARTERIA BLOOD FILTER
K021293
Arteria Medical Science, Inc.
General Hospital · 121d
Cleared Dec 16, 1999
PALL SUPOR AEF FILTER
K993379
Pall Corp.
General Hospital · 70d
Cleared Feb 11, 1998
0.2 U BACTERIAL FILTER
K974661
Sims Deltec, Inc.
General Hospital · 58d
Cleared Jan 22, 1997
AUTOPRIME
K964283
Arbor Technologies, Inc.
General Hospital · 86d
Cleared Jan 09, 1997
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331
Pall Biomedical Products Co.
General Hospital · 482d
Cleared May 19, 1995
I.V. FILTER SET
K933523
Mediziv Medical Products 1987 , Ltd.
General Hospital · 668d
Cleared Feb 16, 1995
40 MICRON BLOOD TRANSFUSION FILTER
K941628
Douglas Medical Products Corp.
General Hospital · 318d
Cleared Oct 07, 1994
1.2 MICRON AIR ELIMINATING FILTER
K942625
The Medi-Dose Group
General Hospital · 127d
Cleared Sep 29, 1994
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127
Gelman Sciences, Inc.
General Hospital · 92d
Cleared Aug 17, 1994
2 MICRON AIR ELIMINATING FILTER
K942532
Medi-Dose, Inc.
General Hospital · 82d
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 Jul 14, 1994
CHARGED SUPOR(R) FILTER EXTENSION SET
K940980
B. Braun of America, Inc.
General Hospital · 135d
Cleared Apr 26, 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869
Baxter Healthcare Corp
General Hospital · 260d
Cleared Mar 28, 1994
1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
K940293
Puritas Health Care, Inc.
General Hospital · 66d
Cleared Feb 09, 1994
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
K933294
Aesculap, Inc.
General Hospital · 217d
Cleared Jan 28, 1994
0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS
K935641
Evans Medical, Inc.
General Hospital · 67d
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

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.