Encompass Group, LLC

FDA Regulatory Profile

Encompass Group, LLC has 0 FDA recalls, 10 inspections, 4 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 2, 2026 · VAI
Latest 510(k)
Nov 12, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections10Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 2, 2026Mcdonough, GADevicesVoluntary Action Indicated (VAI)1043644
Jan 8, 2020Mcdonough, GADevicesNo Action Indicated (NAI)1043644
Oct 12, 2017Richmond, VADevicesVoluntary Action Indicated (VAI)1000150080
Jun 9, 2017Mcdonough, GADevicesVoluntary Action Indicated (VAI)1043644
Dec 30, 2015McAllen, TXDevicesNo Action Indicated (NAI)3001340296
Nov 15, 2013McAllen, TXDevicesNo Action Indicated (NAI)3001340296
Apr 10, 2013Mcdonough, GADevicesNo Action Indicated (NAI)1043644
Jan 20, 2012Addison, TXDevicesVoluntary Action Indicated (VAI)1641118
Jan 26, 2011Mcdonough, GADevicesNo Action Indicated (NAI)1043644
Dec 22, 2009Mcdonough, GADevicesOfficial Action Indicated (OAI)1043644

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
K203085NOVA Patient Warming SystemNov 12, 2020
K982058ROTECNO FR (FLUID RESISTANT) SURGICAL GOWNJan 14, 1999
K982059ROTECNO 2000 SURGICAL GOWNNov 30, 1998
K760618PATIENT RESTRAINTNov 24, 1976