Sleep Science Partners, Inc.

FDA Regulatory Profile

Sleep Science Partners, Inc. has 0 FDA recalls, 4 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 24, 2019 · NAI
Latest 510(k)
Apr 11, 2019

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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
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 24, 2019Larkspur, CADevicesNo Action Indicated (NAI)3006794225
Jun 21, 2016Larkspur, CADevicesOfficial Action Indicated (OAI)3006794225
Feb 11, 2015Larkspur, CADevicesNo Action Indicated (NAI)3006794225
Jan 17, 2014Larkspur, CADevicesNo Action Indicated (NAI)3006794225

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
K190058PureSleep (OTC use)Apr 11, 2019
K113022PURESLEEPJun 11, 2012