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

Ring, Teething, Fluid-Filled

21 CFR 872.5550 / Dental
FDA source (opens on fda.gov)

KKO is the FDA product code for Ring, Teething, Fluid-Filled, a class II device type, regulated under 21 CFR 872.5550. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
KKO
Device name
Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
27
Ingested recalls
9

Clearances, product code KKO

By decision year
27 clearances under product code KKO with a decision year between 1991 and 2013, 2009 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KKO by decision year
YearClearances
19911
19951
19961
19971
19981
20001
20022
20031
20053
20062
20071
20095
20104
20112
20131

Applicants with the most clearances

Product code KKO
Applicants holding the most 510(k) clearances under product code KKO
ApplicantClearances
Fu Hong Industries, Ltd.2
Kids II, Inc.2
Mam International AG2
Allied Hill Enterprises, Ltd.1
Angelina Trading, Inc.1
Babies Best, Inc.1
Bebe Toys Manufactory, Ltd.1
Biomedevice, Ltd.1
Consolidated Stores Corp.1
Cool Baby, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order