510(k) K950419 ยท FRN Pump, Infusion
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
| Applicant | Imed Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 21, 1995 |
| Received | Jan 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2017 | CareFusion 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 |
FRN | None listed |
| Jun 19, 2017 | CareFusion 303, Inc. Alaris Pump Module model 8100 Terminated |
FRN | None listed |
| Jan 18, 2017 | CareFusion 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 |
FRN | None listed |
| May 14, 2014 | CareFusion 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 |
FRN | None listed |
| Aug 17, 2012 | CareFusion 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 |
FRN | None listed |
| Aug 15, 2012 | CareFusion 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 |
FRN | None listed |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health Alaris Pump Module, Model 8100. Terminated |
FRN | None listed |
| Aug 3, 2009 | Cardinal 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 |
FRN | None listed |
| Jun 10, 2008 | Cardinal 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 |
FRN | None listed |
| Jun 10, 2008 | Cardinal 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 |
FRN | None listed |
| Jun 10, 2008 | Cardinal 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 |
FRN | None listed |
| Mar 3, 2005 | Alaris Medical Systems Inc Model 8100 Series Medley Medication Safety System Pump Module Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.