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Apnicure, Inc.

FDA Regulatory Profile

Apnicure, Inc. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 10, 2014 · NAI
Latest 510(k)
Jun 13, 2014

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 10, 2014Redwood City, CADevicesNo Action Indicated (NAI)3008240807

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
K132003WINX SLEEP THERAPY SYSTEMJun 13, 2014
K130538WINX SLEEP THERAPY SYSTEMMay 22, 2013
K122130WINX SLEEP THERAPY SYSTEMOct 31, 2012
K111549ATTUNE SLEEP APNEA SYSTEMMar 30, 2012

FDA data resources