510(k) · Cleared
ClearedFluid Filled Teethers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Royal King Infant Products Co., Ltd. · KKO Ring, Teething, Fluid-Filled
Cleared on Dec 8, 2003 after a 245-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 8, 2003
- Review
- 245 days
- Class
- Class II
- Product code
- KKO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031094 Fluid Filled TeethersRoyal King Infant Products Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK043033 Global Treasures Fluid Filled TeetherGlobal Treasure Industries, Ltd. · 2005
Most influential descendants
Showing 1 of 1 · See all- K043033Global Treasures Fluid Filled TeetherGlobal Treasure Industries, Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031094 | Fluid Filled Teethers | Royal King Infant Products Co., Ltd. | 2003 | — |
| +1 | K043033 | Global Treasures Fluid Filled Teether | Global Treasure Industries, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043033 | Global Treasures Fluid Filled Teether | 2005 | 0 |
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.
What does this lineage say?
- Of its descendants, K043033 (Global Treasure Industries, Ltd., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KKO devicesKKO Ring, Teething, Fluid-Filled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKO
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KKO
240in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKO
1in 2020
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 intended purpose of the fluid filled teether is to relieve the
teething discomfort of infants by giving cool soothing effect
when the cool teether is chewed on.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031094: Fluid Filled Teethers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031094
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026