510(k) Report

Devices descending from K120836

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

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