510(k) Report

Devices descending from K121536

10 later devices reach Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir 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—
+1K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L.201321
+1K122844Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20123—
+2K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L20260—
+2K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.20250—
+2K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L20250—
+2K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.20240—
+2K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…Qura S.R.L20220—
+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—