510(k) Report

Devices descending from K212031

2 later devices reach F&P 850 AirSpiral Adult NIV and NHF Circuit Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+2K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—