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Mr Instruments, Inc.

FDA Regulatory Profile

Mr Instruments, Inc. has 0 FDA recalls, 3 inspections, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 26, 2022 · NAI
Latest 510(k)
Nov 28, 2017

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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) clearances7Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 26, 2022Brooklyn Park, MNDevicesNo Action Indicated (NAI)3003852428
Aug 2, 2017Brooklyn Park, MNDevicesNo Action Indicated (NAI)3003852428
Sep 12, 2011Brooklyn Park, MNDevicesNo Action Indicated (NAI)3003852428

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
K173290DuoFLEX Coil SuiteNov 28, 2017
K130706DUOFLEX COIL SUITE (1.5T)Jul 25, 2013
K110591MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COILMar 29, 2011
K080820TEM 3002G- HN DUAL TUNE HEAD COILApr 2, 2008
K072931MC 3003G-32R HEAD COILOct 30, 2007
K052200TEM 3000 HEAD COILAug 19, 2005
K040937TEM 3000 HEAD COILApr 23, 2004

FDA data resources