510(k) Report

Devices descending from K031883

3 later devices reach Lyra Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061099Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC20060—
+1K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc.20041—
+2K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc.20050—