510(k) Report

Devices descending from K831246

24 later devices reach Whistler in-Line Pressure Release Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040366Pressure Manifold, Model BC 110Fisher & Paykel Healthcare, Ltd.200423—
+2K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical20110Class I
+2K091538Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV…Wet Nose Technologies, LLC20101—
+2K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K111191Audible Pressure Release Valve with Humidifier Adapter / and Oxygen NippleWet Nose Technologies, LLC20110—
+3K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+4K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+5K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+5K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+6K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+6K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+6K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+6K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+7K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+7K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+7K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—