Atlas FDA

LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

FDA 510(k) clearance K042800 · decided 2004-10-18

Clearance details

K-number
K042800
Device name
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2004-10-08
Decision date
2004-10-18
Days to decision
10 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, US
Third-party review
Yes
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054)Harvard Clinical Technology2003-12-16
MEDLEY PCA MODULE, MODEL 8120 (K032233)Alaris Medical Systems, Inc.2003-09-09
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 (K031566)Baxter Healthcare Corp2003-08-19

Recalls involving this device

RecordFirmDate
The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patien recall (Z-1518-2015)Hospira Inc.2015-04-23
LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 2070 recall (Z-0018-2010)Hospira Inc2009-10-06

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30