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Airsep Corp.

FDA Regulatory Profile

Airsep Corp. has 0 FDA recalls, 4 inspections, 19 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 25, 2019 · VAI
Latest 510(k)
Dec 18, 2015

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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) clearances19Oct 4, 2026Not statedCurrent
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 25, 2019Amherst, NYDevicesVoluntary Action Indicated (VAI)3006277965
Jan 4, 2017Amherst, NYDevicesNo Action Indicated (NAI)3006277965
Jun 29, 2011Ball Ground, GADevicesVoluntary Action Indicated (VAI)3010730925
Oct 5, 2009Ball Ground, GADevicesVoluntary Action Indicated (VAI)3010730925

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
K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Dec 18, 2015
K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LMar 28, 2011
K080348OXISCAN II DATA MANAGEMENT SYSTEMOct 9, 2008
K020324LIFESTYLE OXYGEN CONCENTRATORMar 13, 2002
K012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009Jan 17, 2002
K000963DA VINCHI EEG AND EMG/EP SYSTEMSOct 20, 2000
K001579IMPULSE SELECTAug 31, 2000
K001467DA VINCHI EMG/EP ISA1004EPAug 1, 2000
K001013MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHYMay 16, 2000
K992283ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHYAug 27, 1999
K983002MYSTIQUE ULTRASONIC NEBULIZEROct 16, 1998
K960309AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)Feb 28, 1997
K962865REMBRANDT SYSTEMOct 25, 1996
K962766AIRSEP IMPULSEOct 10, 1996
K943207NITELIFE BI-LEVEL CPAPJul 29, 1996
K951882ECO CHECK (ECOVALVE AND OXYGEN MONITOR)Oct 16, 1995
K944020AIRSEP NEWLIFE AIR OUTLET OPTIONMar 16, 1995
K884581RELIANT OXYGEN CONCENTRATORJan 11, 1989
K8725344LYF OXYGEN CONCENTRATOROct 13, 1987

FDA data resources