510(k) Report

Devices descending from K123115

2 later devices reach Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GMedtecs (Taiwan) Corp.20220—
+1K202126Disposable Surgical MaskShenzhen Peninsula Medical Co., Ltd.20210—