510(k) Report

Devices descending from K122180

31 later devices reach High Flow Insufflantion Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+1K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+1K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+2K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+2K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+2K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+3K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+3K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+3K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+3K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+3K190303AirSealConmed Corporation20191—
+4K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+4K250388Endoflator +Karl Storz SE & CO. KG20251—
+4K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+4K230474EVA5 InsufflatorPalliare, Ltd.20231—
+4K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+4K202799EVA15Palliare, Ltd.20204—
+5K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+5K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+5K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+5K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+5K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+5K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+5K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+5K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+5K222901EVA15 insufflatorPalliare, Ltd.20233—
+6K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+6K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+6K232902EVA15 insufflatorPalliare, Ltd.20240—