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Respire Medical

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1947-2018Class IIRespire Pink Series EF+ Oral Sleep Apnea Device.September 1, 2017
Z-1948-2018Class IIRespire Pink+ Hard/Soft Oral Sleep Apnea DeviceSeptember 1, 2017
Z-1951-2018Class IIRespire Pink H/S Oral Sleep Apnea DeviceSeptember 1, 2017
Z-1950-2018Class IIRespire Pink H/S Oral Sleep Apnea DeviceSeptember 1, 2017
Z-1949-2018Class IIRespire Pink+ Hard Oral Sleep Apnea DeviceSeptember 1, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K214096Respire ClearMay 31, 2022
K131138RESPIRE PINK SERIES - HERBSTSeptember 9, 2013
K111207RESPIRE BLUE SERIESAugust 23, 2011