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

Monitor, Electric For Gravity Flow Infusion Systems

21 CFR 880.2420 / General Hospital
FDA source (opens on fda.gov)

FLN is the FDA product code for Monitor, Electric For Gravity Flow Infusion Systems, a class II device type, regulated under 21 CFR 880.2420. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FLN
Device name
Monitor, Electric For Gravity Flow Infusion Systems
Regulation
21 CFR 880.2420
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
39
Ingested recalls
0

Clearances, product code FLN

By decision year
39 clearances under product code FLN with a decision year between 1976 and 2018, 1985 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code FLN by decision year
YearClearances
19761
19771
19785
19792
19804
19821
19832
19856
19861
19891
19902
19911
19931
19972
20011
20021
20031
20062
20081
20141
20151
20181

Applicants with the most clearances

Product code FLN
Applicants holding the most 510(k) clearances under product code FLN
ApplicantClearances
Imed Corp.4
Shift Labs2
Travenol Laboratories, S.A.2
A.R. Nelson Co., Inc.1
Aci Medical, LLC1
Alexander Mfg. Co.1
American Mcgaw1
Baxter Healthcare Corporation1
Centaur Sciences, Inc.1
Coleman Laboratories1

Companies listing this code with FDA

Companies whose registered establishments list this code