510(k) Report

Devices descending from K061435

120 later devices reach Medela Vario Suction Pumps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+6K182191Invia Abdominal Dressing KitMedela AG20190—
+6K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+6K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+6K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+6K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+6K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+6K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC20160—
+6K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+6K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+6K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+7K232379PREVENT KitClear Choice Therapeutics20240—
+7K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+7K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+7K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+7K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+7K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+8K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—
+8K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+9K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—