510(k) Report

Devices descending from K163160

4 later devices reach Sterile Single-use Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232475Disposable infusion set with needleShandong Zhushi Pharmaceutical Group Co., Ltd.20240—
+1K221069Infusion Sets for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd.20220—
+1K221075Infusion Sets for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+1K202437Infusion Sets for Single UseJiangsu Suyun Medical Materials Co., Ltd.20220—