510(k) Report

Devices descending from K832284

16 later devices reach Solution Admin. Set 2C9096 W/10 PVC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150860Nitroglycerin Sets with DUO-VENT SpikeBaxter Healthcare Corporation20150—
+1K981792Solution Administration SetBaxter Healthcare Corp1998145
+2K160007Paclitaxel SetsBaxter Healthcare Corporation20160—
+2K120685Zyno Medical Administration SetZyno Medical, LLC201212—
+3K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…Amsino International, Inc.20260—
+3K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development20241—
+3K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC20160Class I
+3K151151U & U Intravascular Administration SetU&U Medical Technology Co, Ltd.20155—
+3K140783Halo Ambulatory Infusion SystemZyno Medical, LLC20141Class I
+3K132841Zyno Medical Administration SetZyno Medical, LLC201406
+4K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation20240—
+4K230343ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd.20231—
+4K191640TK Intravascular Administration SetAnhui Tiankang Medical Technology Co., Ltd.20200—
+4K173361IV Administration SetB.Braun Medical, Inc.20181—
+5K251814EZ™ IV Administration SetEpic Medical Pte., Ltd.20250—
+5K213778IV Administration SetB.Braun Medical, Inc.20220—