510(k) Report

Devices descending from K034026

12 later devices reach RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160540Flexicare Neonatal Heated Wire Breathing SystemFlexicare Medical Limited.20160—
+1K103767Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd.201210—
+2K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit…Vincent Healthcare Products Limited20260—
+2K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+2K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa20231—
+2K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.20180Class I
+2K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG20161—
+2K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd.20126—
+3K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+3K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+3K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG201701
+3K150900Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.20150—