510(k) Report

Devices descending from K831506

23 later devices reach Disp. Transducer W/Monitoring Kit Trans through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052828Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc.2006221
+2K120624Elcam Disposable Integrated Pressure Transducer (Dipt)Elcam Medical Acal20120—
+2K061573Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc.200620193
+3K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+3K163376Mikro-Cath Pressure CatheterMillar, Inc.20170—
+3K152472Disposable Pressure TransducerZhejiang Haisheng Medical Device Co., Ltd.20160—
+3K151040Art-line Single channel blood pressure system, Art-line Double channel blood pressure…Biometrix, Ltd.20150—
+3K091408Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd.20097—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc.20106—
+5K254074TruPressProcerus Enterprises20260—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K133624Compass CT, Compass CT PortMirador Biomedical20141—
+5K112203Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure…Mirador Biomedical, Inc.20114—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K161408Compass Cast and MAPCenturion Medical Products Corporation20160—
+6K142245EpiAccess SystemEpiep, Inc.20141—
+7K170831EpiAccess SystemEpiep, Inc.20170—