510(k) · Cleared

Cleared

Liquid Filled Ring Teether, Model 03807, Liquid Filled Ring Teether, Models 1962005, 1962011, Liquid Filled Teething

K091198510(k) TraditionalCleared Dec 7, 2009227-day reviewClass II21 CFR 872.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Allied Hill Enterprises, Ltd. · KKO Ring, Teething, Fluid-Filled

Cleared on Dec 7, 2009 after a 227-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Dec 7, 2009
Review: 227 days
Class: Class II
Product code: KKO
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K091198Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KKO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KKO devices

KKO Ring, Teething, Fluid-Filled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KKO

1in 2013

2007high 5 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKO

240in 2010

2007high 240 (2010) · low 147 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KKO

1in 2022

2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KKO

1in 2020

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code KKO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	0	0
2009	5	147	2	0
2010	4	240	0	0
2011	2	—	0	0
2012	0	—	0	0
2013	1	—	0	1
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	2
2019	0	—	0	2
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	1	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K091198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091198: Liquid Filled Ring Teether, Model 03807, Liquid Filled Ring Teether, Models 1962005, 1962011, Liquid Filled Teething.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091198

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026