510(k) Report

Devices descending from K001951

4 later devices reach Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081633Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksPrimed Medical Products, Inc.20083—
+2K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc.20241—
+2K092012Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…Primed Medical Products, Inc.20090—
+3K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc.20250—