510(k) Report

Devices descending from K000697

119 later devices reach Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+7K242931HFT750UMekics Co., Ltd.20250—
+7K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+7K223684F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd.20230—
+7K203357HVT 2.0Vapotherm, Inc.20211—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K161450Hamilton-C3Hamilton Medical AG201732
+8K254078HVT 2.0Vapotherm, Inc.20260—
+8K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K201306Hamilton-C3Hamilton Medical AG20210Class I
+8K201658Hamilton-C6Hamilton Medical AG20201Class I
+9K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—