510(k) Report

Devices descending from K965017

7 later devices reach Regional Anesthesia Trays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSmiths Medical Asd, Inc.20125—
+1K092657Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc.20096—
+2K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…Smiths Medical Asd, Inc.201802
+2K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd.20171—
+2K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc.20171Class I
+3K211649PCEA Syringe SetBaxter Healthcare Corporation20210—
+3K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.20200—