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Somnetics International, Inc.

FDA Regulatory Profile

Somnetics International, Inc. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 28, 2015 · NAI
Latest 510(k)
Nov 30, 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
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 28, 2015Fridley, MNDevicesNo Action Indicated (NAI)3008770104
Jul 17, 2012Fridley, MNDevicesVoluntary Action Indicated (VAI)3008770104

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
K180388Transcend 365 miniCPAP SystemNov 30, 2018
K132127TRANSCEND AUTOOct 17, 2013
K131388TRANSCEND HEATED HUMIDIFIERSep 26, 2013

FDA data resources