Atlas FDA

HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088

FDA 510(k) clearance K060806 · decided 2006-04-21

Clearance details

K-number
K060806
Device name
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2006-03-24
Decision date
2006-04-21
Days to decision
28 days
Clearance type
Special
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain managemen recall (Z-0421-2015)Hospira Inc.2014-11-24
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain managemen recall (Z-0422-2015)Hospira Inc.2014-11-24
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece recall (Z-0095-2015)Hospira Inc.2014-10-24
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece recall (Z-0096-2015)Hospira Inc.2014-10-24
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain managemen recall (Z-2031-2014)Hospira Inc.2014-07-10
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemSta recall (Z-1512-2014)Hospira Inc.2014-05-01
The GemStar Pump is a small and lightweight, single channel infusion device designed for u recall (Z-0349-2014)Hospira Inc.2013-11-21
The GemStar Pump is a small and lightweight, single channel infusion device designed for u recall (Z-1169-2013)Hospira Inc.2013-04-30
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single recall (Z-1159-2013)Hospira Inc.2013-04-26
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single recall (Z-1160-2013)Hospira Inc.2013-04-26
The GemStar Pump is a small and lightweight, single channel infusion device designed for u recall (Z-1116-2013)Hospira Inc.2013-04-15
The GemStar Pump is a small and lightweight, single channel infusion device designed for u recall (Z-1117-2013)Hospira Inc.2013-04-15
GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain recall (Z-1463-2012)Hospira Inc.2012-04-26
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Va recall (Z-2627-2010)Hospira Inc.2010-09-29
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Va recall (Z-2628-2010)Hospira Inc.2010-09-29
Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon recall (Z-2629-2010)Hospira Inc.2010-09-29
Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve, No recall (Z-2630-2010)Hospira Inc.2010-09-29
Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V. Sec recall (Z-2631-2010)Hospira Inc.2010-09-29
Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light Resi recall (Z-2632-2010)Hospira Inc.2010-09-29
Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated Ant recall (Z-2633-2010)Hospira Inc.2010-09-29
Lifeshield, latex-free, MICRO-DRIP, SOLUSET, GEMSTAR 150 ml Burette Pump Set-OL, convertib recall (Z-1337-2010)Hospira Inc.2010-04-15
Lifeshield, latex, free, GEMSTAR Primary Piggyback Pump Set-SL, convertible pin, attached recall (Z-1338-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, HEMA, GEMSTAR, Y-Type Blood Pump Set, nonvented, 110 inch with CLA recall (Z-1339-2010)Hospira Inc.2010-04-15
GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list # 13072-04-01, AC cord manu recall (Z-0014-2010)Hospira Inc2009-10-06
GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03, 13075-04-05 recall (Z-0015-2010)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