Medical Device Manufacturer · US , Lake Forest , IL

Hospira, Inc.

45 submissions · 44 cleared · Since 2004
45
Total
44
Cleared
0
Denied

Hospira, Inc. — FDA 510(k) Submissions

Hospira, Inc. has submitted 45 FDA 510(k) premarket notifications since 2004, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Pump, Infusion, Catheter, Oximeter, Fiber-optic, Pump, Infusion, Pca, Transducer, Blood-pressure, Extravascular . Use the specialty filter in the sidebar to narrow results.

45 devices
1–25 of 45
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
K161469 · FRN Pump, Infusion · General Hospital
Mar 2017 305d
Hospira Extension Set, Hospira Primary Set
K161036 · FPA Set, Administration,... · General Hospital
Jan 2017 268d
Hospira Sapphire Sets
K160492 · MRZ Accessories, Pump, Infusion · General Hospital
Dec 2016 288d
Hospira Administration Sets
K160870 · FPA Set, Administration,... · General Hospital
Jun 2016 63d
LifeCare PCA Infusion System
K143612 · MEA Pump, Infusion, Pca · General Hospital
Apr 2016 476d
Hospira Blood Set
K143087 · FPA Set, Administration,... · General Hospital
Mar 2015 128d
Hospira Primary Sets
K143015 · FPA Set, Administration,... · General Hospital
Feb 2015 128d
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K141789 · FRN Pump, Infusion · General Hospital
Jan 2015 198d
IV Administration
K142622 · FPA Set, Administration,... · General Hospital
Jan 2015 121d
Extension Sets
K142974 · FPA Set, Administration,... · General Hospital
Jan 2015 87d
Hospira Extension Set
K142433 · FPA Set, Administration,... · General Hospital
Dec 2014 101d
Hospira Primary Sets
K142367 · FPA Set, Administration,... · General Hospital
Nov 2014 92d
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K141102 · FRN Pump, Infusion · General Hospital
Jul 2014 70d
ADD-VANTAGE ADDAPTOR
K133602 · LHI Set, I.v. Fluid Transfer · General Hospital
Jan 2014 60d
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
K132276 · KPE Container, I.v. · General Hospital
Nov 2013 113d
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
K121032 · FPA Set, Administration,... · General Hospital
Jun 2012 77d
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · FRN Pump, Infusion · General Hospital
Mar 2012 340d
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
K113683 · FPA Set, Administration,... · General Hospital
Jan 2012 28d
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
K103224 · FPA Set, Administration,... · General Hospital
Jan 2011 67d
INFUSION SETS
K103344 · FPA Set, Administration,... · General Hospital
Dec 2010 25d
HOSPIRA INFUSION BLOOD SETS
K101677 · FPA Set, Administration,... · General Hospital
Aug 2010 57d
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
K090882 · NGT Saline, Vascular Access... · General Hospital
Apr 2010 388d
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
K091268 · DQE Catheter, Oximeter,... · Cardiovascular
Sep 2009 141d
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610 · DRG Transmitters And... · Cardiovascular
Mar 2009 7d
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K081412 · FRN Pump, Infusion · General Hospital
Dec 2008 211d
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