Water Teether / Gum Soother, Various
510(k) K013587
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013587 | Date14 May 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Babies Best Water Teether / Gum Soother, Various
- 510(k) Number
- FDA Product Code
- KKO
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5550
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Ring, Teething, Fluid-Filled, designed to provide relief for infants experiencing teething discomfort. It functions as a soothing oral toy, allowing babies to chew and massage sore gums with a fluid-filled structure that offers cooling and tactile stimulation.
The device is supplied as a single-use item and is intended for home use by caregivers. It is classified as a Class II medical device under FDA regulations (872.5550) and has received FDA 510(k) clearance (K013587) as substantially equivalent to a predicate device. Multiple registration numbers (e.g., 3025436467) correspond to various sizes and variants of the product, which are non-sterile and intended for oral use only.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Babies Best Water Teether / Gum Soother, and how does it provide relief for infants?
The Babies Best Water Teether / Gum Soother is designed as a fluid-filled oral toy to soothe infants experiencing teething discomfort. It functions by allowing babies to chew and massage sore gums, offering both cooling and tactile stimulation through its fluid-filled structure. This dual effect helps alleviate pain and irritation associated with teething.
Are these devices intended for reuse, or are they meant to be used only once?
The Babies Best Water Teether / Gum Soother is explicitly labeled as a single-use item, intended for home use by caregivers. This design ensures hygiene and safety, as it is not meant to be reused after a single use.
What sizes or variants are available for the Babies Best Water Teether / Gum Soother, and how do I identify them?
Multiple registration numbers (e.g., 3025436467, 3002857192, etc.) correspond to different sizes and variants of the product. These variants are not described in clinical terms but are categorized under the same device classification (Ring, Teething, Fluid-Filled). The manufacturer likely differentiates them by size or design features, but exact specifications are not provided in the data.
Is the Babies Best Water Teether / Gum Soother sterile, and what are the storage recommendations?
The device is explicitly stated as non-sterile and intended for oral use only. Since it is a single-use item, storage should follow general hygiene practices for home use. Keep it in a clean, dry place away from direct sunlight or extreme temperatures until use, and discard after one use to maintain safety and hygiene.
How was the regulatory pathway for this device determined, and what does the FDA 510(k) clearance mean?
The Babies Best Water Teether / Gum Soother received FDA 510(k) clearance (K013587) under the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance was granted by the FDA’s Dental (DE) Advisory Committee and falls under the Class II medical device classification (872.5550). The clearance does not indicate its clinical purpose but confirms it meets regulatory standards for safety and effectiveness as a teething aid.