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

Sterilant, Medical Devices

21 CFR 880.6885 / General Hospital
FDA source (opens on fda.gov)

MED is the FDA product code for Sterilant, Medical Devices, a class II device type, regulated under 21 CFR 880.6885. As of , FDA records hold 64 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
MED
Device name
Sterilant, Medical Devices
Regulation
21 CFR 880.6885
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
64
Ingested recalls
21

Clearances, product code MED

By decision year
64 clearances under product code MED with a decision year between 1988 and 2026, 2010 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MED by decision year
YearClearances
19881
19922
19931
19945
19952
19973
19984
19995
20004
20021
20032
20041
20053
20062
20072
20081
20106
20123
20131
20141
20161
20171
20182
20194
20212
20221
20232
20261

Applicants with the most clearances

Product code MED
Applicants holding the most 510(k) clearances under product code MED
ApplicantClearances
STERIS Corporation19
Advanced Sterilization Products5
Cottrell, Ltd.3
Metrex Research3
Medivators Inc3
Best Sanitizers, Inc.2
Ciden Technologies, LLC2
Healthpoint, Ltd.2
Reckitt Benckiser LLC2
Serim Research Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order