510(k) Report

Devices descending from K040545

4 later devices reach Otter Safety Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1424353S Safety Syringe with/without NeedleSincere Medical Device Co., Ltd.20152—
+1K050116Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd.20050—
+2K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd.20161—
+3K212518Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd.20220—