510(k) Report

Devices descending from K121229

12 later devices reach Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L.20185—
+1K122254Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSorin Group Italia S.R.L.20126—
+2K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L20260—
+2K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L20250—
+2K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…Qura S.R.L20220—
+2K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical, Ltd.20201—
+2K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…Sorin Group Italia S.R.L.20200—
+2K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…Sorin Group Italia S.R.L.20200—
+2K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)Chalice Medical, Ltd.20200—
+2K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L.201321
+3K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.20250—
+3K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical, Ltd.20230—