510(k) · Cleared
ClearedBaby Snoopy Water Filled Teether, Model 95367
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delta Enterprise Corporation · KKO Ring, Teething, Fluid-Filled
Cleared on Jun 28, 2006 after a 287-day review. The FDA summary names no predicate by number.
- Decided
- Jun 28, 2006
- Review
- 287 days
- Class
- Class II
- Product code
- KKO
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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 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?
-User is asked to wash teethers in warm, soapy water, rinse clean, and then to chill them in refrigerator
-teether then acts as a cold compress for baby's gums and helps reduce the discomfort of teething
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052513: Baby Snoopy Water Filled Teether, Model 95367.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052513
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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