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Cas Medical Systems, Inc.

FDA Regulatory Profile

Cas Medical Systems, Inc. has 0 FDA recalls, 3 inspections, 32 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 22, 2016 · VAI
Latest 510(k)
Oct 21, 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) clearances32Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 22, 2016Branford, CTDevicesVoluntary Action Indicated (VAI)2244861
Mar 14, 2013Branford, CTDevicesNo Action Indicated (NAI)2244861
Aug 20, 2010Branford, CTDevicesNo Action Indicated (NAI)2244861

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
K190270FORE-SIGHT ELITE Tissue Oximeter ModuleOct 21, 2019
K180003FORE-SIGHT ELITE Module Tissue OximeterMay 10, 2018
K150620740 SELECTMay 8, 2015
K143675FORE-SIGHT Elite Absolute Tissue OximeterApr 10, 2015
K140430740 SELECTJun 13, 2014
K133879FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERApr 29, 2014
K130411740 SELECTMay 29, 2013
K123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERApr 11, 2013
K112820FORE-SIGHT ABSOLUTE TISSUE OXIMETERJan 26, 2012
K094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020…Dec 23, 2010
K091452FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)Aug 21, 2009
K083892FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)Mar 19, 2009
K073036FORE-SIGHT, MC-2000 SERIESFeb 25, 2008
K063087MODIFICATION TO MODEL 750 SERIES MONITORDec 11, 2006
K061960FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040Sep 5, 2006
K051257ADULT CEREBRAL OXIMETER, MODEL 2040Dec 22, 2005
K051896MODEL 750E SERIES MONITORDec 16, 2005
K050844750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL…Jun 23, 2005
K033048CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN…Jun 1, 2004
K000512OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010Sep 26, 2000

FDA data resources