510(k) Report

Devices descending from K041855

15 later devices reach Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090131DS N95 Surgical Masks and Flat SurgicalShanghai Dasheng Health Products20090—
+1K080827Handan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810Handan Hengyong Protective & Clean Products Co., L20080—
+1K072067N95 Surgical Respirator, Type AP0018 and AP0028Shuenn Bao Shing Corporation20080—
+1K070139Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095Survivair, Inc.20075—
+1K051182Inovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC2005111
+2K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture…Pasture Pharma Pte, Ltd.20150—
+2K102173Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712Moldex/Metric, Inc.20100—
+2K070782Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models…Survivair Respirators, LLC20073—
+2K063747Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S…Inovel, LLC20070—
+2K062665Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC20061—
+2K062663Moldex Health Care N95 Particulate Respirators and Surgical MasksMoldex/Metric, Inc.20060—
+2K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC20063—
+3K081923Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare20092—
+4K093189Actiprotect UC N95 RespiratorGlaxosmithkline Consumer Healthcare20100—
+4K093161Actiprotect UF N95 RespiratorGlaxosmithkline Consumer Healthcare20100—