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Newport Medical Instruments Inc

FDA Regulatory Profile

Summary

Total Recalls
3 (3 Class I)
510(k) Clearances
23
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1874-2017Class INewport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family March 30, 2017
Z-1171-2013Class INewport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 aApril 5, 2013
Z-2250-2012Class INewport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HTAugust 3, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K121891NEWPORT AURA VENTILATORNovember 9, 2012
K111146NEWPORT HT70 VENTILATORDecember 1, 2011
K101803NEWPORT E360 VENTILATORSeptember 8, 2010
K090888NEWPORT HT70 FAMILY OF VENTILATORSNovember 18, 2009
K082724NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEMDecember 16, 2008
K061094NEWPORT E500 WAVE VENTILATORJuly 28, 2006
K053502NEWPORT E360 VENTILATORJanuary 10, 2006
K041406NEWPORT C250 AIR COMPRESSOR MODEL C250December 15, 2004
K041082NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZERSeptember 7, 2004
K030780NEWPORT E500 WAVE VENTILATORJanuary 23, 2004
K992133NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1,August 4, 2000
K972833E100M VENTILATOR (E100M)September 23, 1999
K941308NEWPORT ELECTRONIC MANOMETERAugust 25, 1995
K940739NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTORMarch 7, 1995
K941309NEWPORT ELECTRONIC MANOMETERMarch 6, 1995
K931542NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOROctober 25, 1993
K901785NEWPORT WAVE VENTILATOR MODEL E200August 10, 1990
K883809NEWPORT VENTILATOR MODEL E150June 23, 1989
K860373THE M100 AIR/OXYGEN MIXERMay 21, 1986
K860438NEWPORT VENTILATOR MODEL E-100May 6, 1986