510(k) Report

Devices descending from K103767

10 later devices reach Dual Heated Infant Vreathing Cirouits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit…Vincent Healthcare Products Limited20260—
+1K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+1K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa20231—
+1K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.20180Class I
+1K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG20161—
+1K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd.20126—
+2K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+2K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+2K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG201701
+2K150900Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.20150—