510(k) Report

510(k) · Cleared

Cleared

Baby Teether, Model 20104

K014023510(k) TraditionalCleared Aug 2, 2002239-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

Angelina Trading, Inc. · KKO Ring, Teething, Fluid-Filled

Cleared on Aug 2, 2002 after a 239-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Aug 2, 2002
Review
239 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 K014023Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • 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.

FDA decisions per year · KKO

1in 2013

2007: 12009: 52010: 42011: 22013: 1
2007high 5 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKO

240in 2010

2009: 147 days median2010: 240 days median
2007high 240 (2010) · low 147 (2009)2026

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

Recalls per year · KKO

1in 2022

2009: 22022: 1
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

2013: 12018: 22019: 22020: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
2009514720
2010424000
20112—00
20120—00
20131—01
20140—00
20150—00
20160—00
20170—00
20180—02
20190—02
20200—01
20210—00
20220—10
20230—00
20240—00
20250—00
20260—0—

Recent decisions in KKO

The KKO category page

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  • K110615Water Filled Teether, Water Filled Teether with HandleBebe Toys Manufactory, Ltd. · 2011
  • K092025Fluid Filled Teether - GelKids II · 2011
  • K093266Mam CoolerMam International AG · 2010
  • K092781Mam TwisterMam International AG · 2010

https://510kreport.com/device/K014023 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014023: Baby Teether, Model 20104.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014023

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026