510(k) Report

Devices descending from K122254

6 later devices reach Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical, Ltd.20201—
+1K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)Chalice Medical, Ltd.20200—
+1K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L.201321
+2K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.20250—
+2K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical, Ltd.20230—
+2K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…Sorin Group Italia S.R.L.20200—