510(k) Report

510(k) · Cleared

Cleared

Jeje Teether

K034017510(k) TraditionalCleared Oct 18, 2004299-day reviewClass I21 CFR 872.5550

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

Vibe 2000 · MEF Ring, Teething, Non-Fluid Filled

Cleared on Oct 18, 2004 after a 299-day review. The FDA summary names its predicate without a number.

Decided
Oct 18, 2004
Review
299 days
Class
Class I
Product code
MEF
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K034017Source: 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 summary (predicates and 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Class I non-fluid filled teething rings
Named without a submission 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 MEF devices

MEF Ring, Teething, Non-Fluid Filled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEF

FDA has decided no MEF device since 2007.

Median 510(k) review, days · MEF

Too few MEF 510(k)s in any year since 2007 to give a median.

Recalls per year · MEF

No recall names MEF since 2007.

Adverse event reports per year · MEF

2in 2021

2011: 12014: 12018: 102019: 142020: 12021: 2
2007high 14 (2019) · low 0 (2007)2025

MAUDE reports naming product code MEF, 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
20070—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—010
20190—014
20200—01
20210—02
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K034017 · printed Nov 3, 2026

Cite this page

510(k) Report. “K034017: Jeje Teether.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034017

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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