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
MEBClass II

Pump, Infusion, Elastomeric

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

MEB is the FDA product code for Pump, Infusion, Elastomeric, a class II device type, regulated under 21 CFR 880.5725. As of , FDA records hold 88 510(k) clearances under this code, the most recent dated , and 109 recalls.

Classification record

Product code
MEB
Device name
Pump, Infusion, Elastomeric
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
88
Ingested recalls
109

Clearances, product code MEB

By decision year
88 clearances under product code MEB with a decision year between 1992 and 2026, 2002 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code MEB by decision year
YearClearances
19923
19931
19945
19954
19965
19974
19986
19997
20006
20016
20028
20032
20045
20055
20066
20075
20082
20091
20131
20141
20161
20191
20242
20261

Applicants with the most clearances

Product code MEB
Applicants holding the most 510(k) clearances under product code MEB
ApplicantClearances
Halyard Health18
Baxter Healthcare Corporation8
Novacon Corp.6
Advanced Infusion, Inc.5
Breg, Inc.5
Epic Medical Pte., Ltd.3
Mckinley, Inc.3
Mps Acacia3
Symbios Medical Products, LLC3
Ace Medical Us, LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order