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Iterative Health

FDA Regulatory Profile

Iterative Health has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Dec 22, 2025

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) Clearances

K-NumberDeviceDate
K253664SKOUT systemDec 22, 2025
K251126SKOUT systemMay 9, 2025

FDA data resources

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