510(k) Report

Devices descending from K002040

10 later devices reach FMS Solo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132883Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas20130—
+1K130169FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company20135—
+1K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc.20052—
+2K233675FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc.20240—
+2K192921Zeos Aqua Vision Pump and tubeHemodia Sas20202—
+2K171237FMS VUE II Fluid Management and Tissue Debridement SystemMedos International SARL20180—
+2K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.200516
+3K203480DOUBLEFLO systemHemodia Sas20211—
+3K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.20170—
+4K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas20230—