510(k) Report

Devices descending from K051291

20 later devices reach Non-Sterile Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212273Cross Protection ResQ300 Plus Surgical Face MaskCross Protection (M) Sdn Bhd20220—
+1K203425Surgical MaskBdc Dental Corporation, Ltd.20210—
+1K110027Surgical Face Mask; Surgical Face MaskAngeline Group, Ltd.20110—
+1K100800Tidi FacemaskTidi Products,Llc20100—
+1K092580Tidi FacemaskTidi Products,Llc20109—
+1K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop…Dukal Corp.20070—
+1K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp.20066—
+2K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd.20153—
+2K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd.20114—
+2K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company20103—
+3K202577Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd.20210—
+3K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20201—
+3K201137Asept Surgical Face MaskPfm Medical, Inc.20203—
+3K152197Skypro, SP01 MaskSkypro Medical Supplies Company20162—
+4K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—
+4K202255Skypro, SP02 Mask (3)Skypro Medical Supplies Company20210—
+4K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd.20210—
+4K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd.20211—
+4K203646Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology Co., Ltd.20210—
+5K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—