510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
MEAClass II

Pump, Infusion, Pca

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

MEA is the FDA product code for Pump, Infusion, Pca, a class II device type, regulated under 21 CFR 880.5725. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 46 recalls.

Classification record

Product code
MEA
Device name
Pump, Infusion, Pca
Regulation
21 CFR 880.5725
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
No
Ingested clearances
31
Ingested recalls
46

Clearances, product code MEA

By decision year
31 clearances under product code MEA with a decision year between 1991 and 2017, 2003 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MEA by decision year
YearClearances
19913
19923
19931
19941
19951
19981
19991
20002
20022
20036
20043
20051
20081
20091
20131
20161
20172

Applicants with the most clearances

Product code MEA
Applicants holding the most 510(k) clearances under product code MEA
ApplicantClearances
Abbott Medical6
Baxter Healthcare Corporation3
CareFusion 303, Inc2
C.R. Bard Inc2
Pharmacia Deltec, Inc.2
Amtec Medical1
B.Braun Medical, Inc.1
Baxa Corp., Sub. of Cook Group, Inc.1
Block Medical, Inc.1
Cane S.r.l.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order