Hsiner Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251888VPAP Pediatric Face MaskMarch 12, 2026
K102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 102August 12, 2011
K09118570530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTERJuly 24, 2009
K082009HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDSAugust 22, 2008
K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235February 23, 2007
K053466HSINER RESUSCITATORMarch 22, 2006
K052811HSINER JET NEBULIZER, MODEL HS-31100December 21, 2005