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Intuity Medical, Inc.

FDA Regulatory Profile

Intuity Medical, Inc. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 19, 2022 · VAI
Latest 510(k)
Jun 14, 2018

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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
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 19, 2022Fremont, CADevicesVoluntary Action Indicated (VAI)3013750448

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
K181316POGO Automatic Blood Glucose Monitoring SystemJun 14, 2018
K162203POGO Automatic Blood Glucose Monitoring SystemApr 6, 2017
K152493POGO Automatic Blood Glucose Monitoring SystemApr 25, 2016

FDA data resources