Apnea Sciences Corporation

FDA Regulatory Profile

Apnea Sciences Corporation has 0 FDA recalls, 7 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Sep 18, 2024 · NAI
Latest 510(k)
Aug 18, 2017

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections7Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 18, 2024Henderson, NVDevicesNo Action Indicated (NAI)3009549393
Aug 19, 2021Henderson, NVDevicesNo Action Indicated (NAI)3009549393
Jul 16, 2018Henderson, NVDevicesVoluntary Action Indicated (VAI)3009549393
Nov 12, 2015Henderson, NVDevicesOfficial Action Indicated (OAI)3009549393
Sep 18, 2015Henderson, NVDevicesOfficial Action Indicated (OAI)3009549393
Jan 28, 2014Henderson, NVDevicesOfficial Action Indicated (OAI)3009549393
Dec 6, 2012Henderson, NVDevicesOfficial Action Indicated (OAI)3009549393

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
K170825SnoreRxAug 18, 2017
K153200SnoreRxAug 9, 2016