510(k) Report

Devices descending from K974068

4 later devices reach PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft…Owens & Minor (O&M) Halyard, Inc.20240—
+1K102092Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP CeriesPrestige Ameritech20102—
+2K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.20161—
+3K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.20180—