Kids II FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Kids II has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kids II" is on file.

What these totals cover: FDA records filed under the name "Kids II".

Latest inspection
Apr 18, 2019 · VAI
Latest 510(k)
Jan 27, 2011

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Apr 18, 2019.

DateSiteProductClassificationFEI
Apr 18, 2019Atlanta, GADevicesVoluntary Action Indicated (VAI)3007154355
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3007154355Atlanta, GA1Apr 18, 2019

Recent 510(k) clearances

2 510(k) clearances from May 27, 2009 to Jan 27, 2011.

K-NumberDeviceDate
K092025FLUID FILLED TEETHER - GELJan 27, 2011
K082824FLUID FILLED TEETHERMay 27, 2009

Kids II and the FDA: common questions

Has Kids II received an FDA warning letter?

No FDA warning letter addressed to the name "Kids II" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Kids II received an FDA Form 483?

FDA has not published a Form 483 for "Kids II" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kids II?

The most recent FDA inspection on file ended Apr 18, 2019 at Atlanta, GA and was classified VAI. FDA has 1 inspection of Kids II on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.