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

Sterilizer, Dry Heat

21 CFR 880.6870 / General Hospital
FDA source (opens on fda.gov)

KMH is the FDA product code for Sterilizer, Dry Heat, a class II device type, regulated under 21 CFR 880.6870. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KMH
Device name
Sterilizer, Dry Heat
Regulation
21 CFR 880.6870
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
10
Ingested recalls
0

Clearances, product code KMH

By decision year
10 clearances under product code KMH with a decision year between 1977 and 2011, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KMH by decision year
YearClearances
19771
19851
19872
19882
19911
19921
20051
20111

Applicants with the most clearances

Product code KMH
Applicants holding the most 510(k) clearances under product code KMH
ApplicantClearances
Cox Sterile Products, Inc.3
Dentronix, Inc.2
Broadwest Corp.1
Coltene /Whaledent AG1
Cpac, Inc.1
Cpac, Inc.1
Lorvic Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code