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Zephyr Sleep Technologies

FDA Regulatory Profile

Zephyr Sleep Technologies has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 8, 2015 · VAI
Latest 510(k)
Aug 24, 2020

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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) clearances7Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 8, 2015Calgary, CanadaDevicesVoluntary Action Indicated (VAI)3008960597

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
K200695MATRx plusAug 24, 2020
K191925MATRx PlusOct 29, 2019
K190051TD ClipJun 7, 2019
K181996MATRx PlusNov 21, 2018
DEN170090MATRx plusAug 23, 2018
K163665MATRx plusMay 5, 2017
K103704REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMPMar 23, 2012

FDA data resources