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

Utensil, Homemaking

21 CFR 890.5050 / Physical Medicine
FDA source (opens on fda.gov)

IKW is the FDA product code for Utensil, Homemaking, a class I device type, regulated under 21 CFR 890.5050. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IKW
Device name
Utensil, Homemaking
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code IKW

By decision year
12 clearances under product code IKW with a decision year between 1976 and 1983, 1982 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code IKW by decision year
YearClearances
19764
19791
19811
19825
19831

Applicants with the most clearances

Product code IKW
Applicants holding the most 510(k) clearances under product code IKW
ApplicantClearances
Fred Sammons, Inc.12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order