510(k) Report

Devices descending from K113053

8 later devices reach Bipap a 30 Ventilatory Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+1K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+2K181166Trilogy EvoRespironics, Inc.20195Class I
+3K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+3K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+4K233452Vivo 45 LSBreas Medical AB202501