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Fifth Eye, Inc.

FDA Regulatory Profile

Fifth Eye, Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jul 14, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections0Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K221203AHI SystemJul 14, 2022
K212219AHI SystemDec 3, 2021
DEN200022Analytic for Hemodynamic Instability (AHI)Mar 1, 2021

FDA data resources