510(k) Report

Devices descending from K111034

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150143Normal Saline FlushNurse Assist, Inc.20150Class I
+1K1208360.9% Sodium Chloride Flish SyringeAm USA201262
+1K113555AM Usa 0.9% Sodium Chloride Flush SyringeAm USA201201
+2K1336850.9% Sodium Chloride Flush SyringeAm USA201451
+3K183473AMSafe (R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.20194—
+4K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt., Ltd.20230—
+4K213522AMSafe Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.20222—
+5K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.20230—
+5K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.20230—