ClearanceBrief
510(k) K950419 ยท FRN Pump, Infusion

THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS

ApplicantImed Corp., San Diego CA, US
DecisionSubstantially Equivalent, Jun 21, 1995
ReceivedJan 31, 1995
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K950419

DateFirm and productCodeLinked 510(k)
Aug 9, 2017CareFusion 303, Inc.
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Al
Open, Classified
FRNNone listed
Jun 19, 2017CareFusion 303, Inc.
Alaris Pump Module model 8100
Terminated
FRNNone listed
Jan 18, 2017CareFusion 303, Inc.
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module
Terminated
FRNNone listed
May 14, 2014CareFusion 303, Inc.
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under th
Terminated
FRNNone listed
Aug 17, 2012CareFusion 303, Inc.
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, bl
Terminated
FRNNone listed
Aug 15, 2012CareFusion 303, Inc.
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using
Terminated
FRNNone listed
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
Alaris Pump Module, Model 8100.
Terminated
FRNNone listed
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analges
Terminated
FRNNone listed
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130
Terminated
FRNNone listed
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Uni
Terminated
FRNNone listed
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe mod
Terminated
FRNNone listed
Mar 3, 2005Alaris Medical Systems Inc
Model 8100 Series Medley Medication Safety System Pump Module
Terminated
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.