510(k) Report

Devices descending from K120685

12 later devices reach Zyno Medical Administration Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…Amsino International, Inc.20260—
+1K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development20241—
+1K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC20160Class I
+1K151151U & U Intravascular Administration SetU&U Medical Technology Co, Ltd.20155—
+1K140783Halo Ambulatory Infusion SystemZyno Medical, LLC20141Class I
+1K132841Zyno Medical Administration SetZyno Medical, LLC201406
+2K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation20240—
+2K230343ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd.20231—
+2K191640TK Intravascular Administration SetAnhui Tiankang Medical Technology Co., Ltd.20200—
+2K173361IV Administration SetB.Braun Medical, Inc.20181—
+3K251814EZ™ IV Administration SetEpic Medical Pte., Ltd.20250—
+3K213778IV Administration SetB.Braun Medical, Inc.20220—