510(k) Report

Devices descending from K093633

12 later devices reach Infinity Acute Care System Workstation Critical Care through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222024Evita V800, Evita V600Draegerwerk AG & CO Kgaa20231—
+1K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+1K181695Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc.201841
+1K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+1K133886Perseus A500Draeger Medical GmbH20142Class I
+2K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa20260—
+2K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+2K192307Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc.202031
+3K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+3K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+3K222644Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc.20231—
+4K251165Saans (F4-01-00-000-000)Innaccel Technologies Private Limited20260—