510(k) Report

Devices descending from K871157

12 later devices reach C.P.a.P. Nasal Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…Fisher & Paykel Healthcare, Ltd.20250—
+1K093716Babi Plus Infant Nasal Cannula SystemA Plus Medical20103—
+1K032922Clarissa Infant Ncpap CannulaAirways Ltd., Inc.20047—
+2K110471Babi Plus Infant Nasal Cannula SystemA Plus Medical20111—
+2K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical20110Class I
+2K090935Minime Pediatric MaskSleepnet Corporation20095—
+3K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+3K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation20120—
+3K102224Pixi Pediatric MaskResmed, Ltd.20103—
+4K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+4K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+5K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—