Cleared Traditional

K031094 - FLUID FILLED TEETHERS

K031094 is an FDA 510(k) clearance for FLUID FILLED TEETHERS, manufactured by Royal King Infant Products Co. , Ltd.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K031094 · Royal King Infant Products Co. , Ltd. · Dental device
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Dec 2003
Decision
245d
Days
Class 2
Risk

K031094 is an FDA 510(k) clearance for the FLUID FILLED TEETHERS. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Royal King Infant Products Co. , Ltd. (Krathumbaen, Samutsakor, TH). The FDA issued a Cleared decision on December 8, 2003 after a review of 245 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5550 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Royal King Infant Products Co. , Ltd. devices

FDA 510(k) Submission Details - K031094

510(k) Number K031094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date December 08, 2003
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKO Device Classification - Class 2, Special Controls

Product Code KKO Ring, Teething, Fluid-filled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KKO Ring, Teething, Fluid-filled

Devices cleared under the same product code (KKO) and FDA review panel - the closest regulatory comparables to K031094.
WATER-FILLED TEETHER
K123855 · Solid Toys Ind. , Ltd. · May 2013
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
K110615 · Bebe Toys Manufactory , Ltd. · Dec 2011
WATER FILLED GUM SOOTHER
K981202 · Corium Corp. · Jun 1998
SOOTHING WATER-FILLED TEETHER
K965082 · Consolidated Stores Corp. · Mar 1997
TYCO BABY SESAME STREET SOFT TEETHER
K963912 · Regu-Tech Assoc., Inc. · Nov 1996