510(k) Report

Devices descending from K950771

4 later devices reach Disposable Adhesive Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123176Iso-Gard Clearair MaskTeleflexmedical, Inc.20132—
+1K071915Cpap MaskArcimed Laboratories, LLC20080—
+2K132729Iso-Gard MaskTeleflexmedical, Inc.20141—
+3K142138Iso-Gard MaskTeleflexmedical, Inc.20140—