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Renalytix Ai, Inc.

FDA Regulatory Profile

Renalytix Ai, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Apr 11, 2025 · VAI
Latest 510(k)
Jun 29, 2023

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 11, 2025Long Island City, NYDevicesVoluntary Action Indicated (VAI)3018739912
Mar 1, 2022Long Island City, NYDevicesNo Action Indicated (NAI)3018739912

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
DEN200052KidneyIntelX.dkdJun 29, 2023

FDA data resources