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

Mirror, Ent

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KAI is the FDA product code for Mirror, Ent, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KAI
Device name
Mirror, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
1

Clearances, product code KAI

By decision year
9 clearances under product code KAI with a decision year between 1977 and 1984, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KAI by decision year
YearClearances
19772
19791
19824
19831
19841

Applicants with the most clearances

Product code KAI
Applicants holding the most 510(k) clearances under product code KAI
ApplicantClearances
Kelleher Corp.2
Treace Medical, Inc.2
Welch Allyn Inc2
Arleton Technical Products, Inc.1
JEDMED Instrument Company1
Microtek Medical LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 102 companies shown, in name order