510(k) Report

Devices descending from K133685

5 later devices reach 0.9% Sodium Chloride Flush Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.20194—
+2K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd.20230—
+2K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.20222—
+3K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.20230—
+3K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.20230—