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Somna Therapeutics, LLC

FDA Regulatory Profile

Somna Therapeutics, LLC has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 13, 2018 · NAI
Latest 510(k)
Apr 13, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 13, 2018Germantown, WIDevicesNo Action Indicated (NAI)3011656501

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
K173934Reza Band, Reflux BandApr 13, 2018
DEN130046REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICEMar 6, 2015

FDA data resources