510(k) Report

Devices descending from K951254

114 later devices reach Safetyglide Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte., Ltd.20250—
+6K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+6K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+6K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+6K241735ProSeal™ In Line Pump Set (423850)Epic Medical Pte., Ltd.20240—
+6K241823ToxiSeal™ Vial AdaptorEpic Medical Pte., Ltd.20240—
+6K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)Epic Medical Pte., Ltd.20240—
+6K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+6K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+6K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+6K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—
+7K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+8K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+8K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—