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Somnics, Inc.

FDA Regulatory Profile

Somnics, Inc. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 5, 2025 · NAI
Latest 510(k)
Jun 16, 2023

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

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 5, 2025Xin Zhu Xian, TaiwanDevicesNo Action Indicated (NAI)3014674517

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
K220907The iNAP One Sleep Therapy SystemJun 16, 2023
K152660HYPNOSPADNov 9, 2016

FDA data resources