510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FPBClass II

Filter, Infusion Line

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

FPB is the FDA product code for Filter, Infusion Line, a class II device type, regulated under 21 CFR 880.5440. As of , FDA records hold 98 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
FPB
Device name
Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
99
Ingested recalls
8

Clearances, product code FPB

By decision year
99 clearances under product code FPB with a decision year between 1977 and 2026, 1977 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code FPB by decision year
YearClearances
197711
19782
19798
19804
19815
19825
19836
19846
19859
19865
19873
19884
19892
19901
19913
19921
19933
199410
19952
19972
19981
19991
20021
20111
20151
20241
20261

Applicants with the most clearances

Product code FPB
Applicants holding the most 510(k) clearances under product code FPB
ApplicantClearances
Abbott Medical11
Tri-Med, Inc.8
Pall Biomedical Products Co.7
Alltek, Inc.4
Baxter Healthcare Corporation4
Jelco Laboratories4
Travenol Laboratories, S.A.4
Churchill Corp.3
Gelman Sciences, Inc.3
Sartorius Filters, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order