510(k) Report

Devices descending from K011404

17 later devices reach Fabius GS Anesthesia System, Model Fabius GS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030624Modification to Fabius GS Anesthesia SystemDraeger Medical, Inc.200415—
+1K031400Fabius Tiro Anesthesia SystemDraeger Medical, Inc.200315—
+2K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.200414—
+3K042607Primus USDraeger Medical, Inc.2004102
+3K042086Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20042—
+4K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+4K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+4K133886Perseus A500Draeger Medical GmbH20142Class I
+4K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+4K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc.20041Class I
+5K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+5K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+5K072884Fabius MriDraeger Medical AG & Co. KG20080Class I
+6K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+6K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—