510(k) Report

Devices descending from K060044

7 later devices reach Acute Care Face Mask, Model RT040 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…Fisher and Paykel Healthcare Limited20171—
+1K083122Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd.20094—
+2K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited20200—
+2K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+2K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+3K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+4K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—