510(k) Report

Devices descending from K081524

2 later devices reach Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd.20171—
+2K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.20200—