Cleared Traditional

K981202 - WATER FILLED GUM SOOTHER

K981202 is an FDA 510(k) clearance for WATER FILLED GUM SOOTHER, manufactured by Corium Corp.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K981202 · Corium Corp. · Dental device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jun 1998

Decision

75d

Days

Class 2

Risk

K981202 is an FDA 510(k) clearance for the WATER FILLED GUM SOOTHER. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Corium Corp. (Monroe, US). The FDA issued a Cleared decision on June 16, 1998 after a review of 75 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 - K981202

510(k) Number	K981202 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 02, 1998
Decision Date	June 16, 1998
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

53d faster than avg

Panel avg: 128d · This submission: 75d

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 K981202.

BABY TEETHER, MODEL 20104

K014023 · Angelina Trading, Inc. · Aug 2002

BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS

K013587 · Babies Best, Inc. · May 2002

FREEZER TEETHER

K002066 · Cool Baby, Inc. · Sep 2000

SOOTHING WATER-FILLED TEETHER

K965082 · Consolidated Stores Corp. · Mar 1997

TYCO BABY SESAME STREET SOFT TEETHER

K963912 · Regu-Tech Assoc., Inc. · Nov 1996

PLAYSKOOL

K955069 · Hasbro, Inc. · Dec 1995

FDA 510(k) Resources - Dental

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K981202

Corium Corp.

Monroe, LA · US

JOSEPH HAKIM

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Dental

View all devices by Corium Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: June 16, 1998. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,325

Regulatory data since 1976

FDA monthly sync October 7, 2026