510(k) Report

Devices descending from K021368

119 later devices reach Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+8K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+8K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+8K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+8K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+8K190028UNO 30Genadyne Biotechnologies20201—
+8K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+8K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+8K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+8K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+8K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+8K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+8K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+9K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+9K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+9K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+9K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+9K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+10K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—