510(k) · Cleared
ClearedGlobal Treasures Fluid Filled Teether
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Treasure Industries, Ltd. · KKO Ring, Teething, Fluid-Filled
Cleared on Mar 22, 2005 as substantially equivalent to K031094 (Royal King Infant Products Co., Ltd., 2003) after a 139-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Mar 22, 2005
- Review
- 139 days
- Class
- Class II
- Product code
- KKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031094 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031094 Fluid Filled TeethersRoyal King Infant Products Co., Ltd. · 2003
- This deviceK043033 Global Treasures Fluid Filled TeetherGlobal Treasure Industries, Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031094 | Fluid Filled Teethers | Royal King Infant Products Co., Ltd. | 2003 | — |
| 0 (this device) | K043033 | Global Treasures Fluid Filled Teether | Global Treasure Industries, Ltd. | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031094 | Fluid Filled TeethersSummary page 1…equivalett h The Global Fluid Filled Teether is substantially (K03 1094). by Royal King Infant Products Company Limited… | 2003 |
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.
What does this lineage say?
- Its one ancestor has no recall.
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 use of the fluid filled teether is to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
The Global Fluid Filled Teether is intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043033: Global Treasures Fluid Filled Teether.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043033
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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