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

Dropper, Ent

21 CFR 874.5220 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KCM is the FDA product code for Dropper, Ent, a class I device type, regulated under 21 CFR 874.5220. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KCM
Device name
Dropper, Ent
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
2

Clearances, product code KCM

By decision year
1 clearance under product code KCM with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KCM by decision year
YearClearances
19841

Applicants with the most clearances

Product code KCM
Applicants holding the most 510(k) clearances under product code KCM
ApplicantClearances
E.W. Link, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order