510(k) Report

Devices descending from K173060

2 later devices reach F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+2K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—