510(k) Report

Devices descending from K161582

4 later devices reach DORA Tubing Sets for Hemodialysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd.20210—
+1K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.20212—
+2K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.20260—
+2K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.20260—