510(k) Report

Devices descending from DEN170001

4 later devices reach Precision Flow® HVNI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+1K221318HVT 2.0Vapotherm, Inc.20220—
+2K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+3K242931HFT750UMekics Co., Ltd.20250—