Cleared Traditional

K093370 - FU HONG INDUSTRIES LIMITED SOOTHER TEETHER

K093370 is an FDA 510(k) clearance for FU HONG INDUSTRIES LIMITED SOOTHER TEETHER, manufactured by Fu Hong Industries , Ltd.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K093370 · Fu Hong Industries , Ltd. · Dental device
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Jan 2010
Decision
84d
Days
Class 2
Risk

K093370 is an FDA 510(k) clearance for the FU HONG INDUSTRIES LIMITED SOOTHER TEETHER. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Fu Hong Industries , Ltd. (Greenwood Village, US). The FDA issued a Cleared decision on January 21, 2010 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K093370

510(k) Number K093370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2009
Decision Date January 21, 2010
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
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

All 26
Devices cleared under the same product code (KKO) and FDA review panel - the closest regulatory comparables to K093370.
MAM COOLER
K093266 · Mam International AG · Jul 2010
MAM TWISTER
K092781 · Mam International AG · Jun 2010
GEL FILLED GUM SOOTHER
K092494 · Luv N' Care, Ltd. · Mar 2010
FLUID-FILLED TEETHER
K092910 · Qualiman Industrial Co., Ltd. · Dec 2009
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
K091198 · Allied Hill Enterprises, Ltd. · Dec 2009
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
K090167 · Philips Electronics UK Limited · Jun 2009
K093370 · FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
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