Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Hospira, Inc. · Predicate Candidate Screening

45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time
288 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug anHospira, Inc.2017-03-283054
K161036Hospira Extension Set, Hospira Primary SetHospira, Inc.2017-01-062680
K160492Hospira Sapphire SetsHospira, Inc.2016-12-062880
K160870Hospira Administration SetsHospira, Inc.2016-06-01630
K143612LifeCare PCA Infusion SystemHospira, Inc.2016-04-084760
K143087Hospira Blood SetHospira, Inc.2015-03-041280
K143015Hospira Primary SetsHospira, Inc.2015-02-251280
K141789PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUHospira, Inc.2015-01-161983
K142622IV AdministrationHospira, Inc.2015-01-151210
K142974Extension SetsHospira, Inc.2015-01-09870
K142433Hospira Extension SetHospira, Inc.2014-12-081010
K142367Hospira Primary SetsHospira, Inc.2014-11-25920
K141102HOSPIRA MEDNET MEDICATION MANAGEMENT SUITEHospira, Inc.2014-07-08700
K133602ADD-VANTAGE ADDAPTORHospira, Inc.2014-01-24600
K132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS COHospira, Inc.2013-11-121130
K121032PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTEHospira, Inc.2012-06-21770
K110901SYMBIQ INFUSION AND ADMINSTRATION SETHospira, Inc.2012-03-053404
K113683LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEALHospira, Inc.2012-01-12280
K103224HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW Hospira, Inc.2011-01-07672
K103344INFUSION SETSHospira, Inc.2010-12-10250
K101677HOSPIRA INFUSION BLOOD SETSHospira, Inc.2010-08-115712
K090882FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDEHospira, Inc.2010-04-233883
K091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETEHospira, Inc.2009-09-181410
K090610HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEMHospira, Inc.2009-03-1370
K081412PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWHospira, Inc.2008-12-1721117
K083019GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOHospira, Inc.2008-10-22138
K080579EFFECTIV (TM) CAPHospira, Inc.2008-09-111920
K070398HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391Hospira, Inc.2007-04-247121
K063180ISECURE SYRINGE CARTRIDGE HOLDERHospira, Inc.2006-12-11530
K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MHospira, Inc.2006-12-11467
K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIHospira, Inc.2006-11-03320
K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, Inc.2006-10-051200
K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KITHospira, Inc.2006-09-19104193
K061432HOSPIRA ENTERAL FEEDING SET, MODEL 20640Hospira, Inc.2006-09-111100
K061450HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-Hospira, Inc.2006-08-04710
K061159OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITHospira, Inc.2006-06-26610
K060806HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087Hospira, Inc.2006-04-212825
K052828DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)Hospira, Inc.2006-02-171350
K052722LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AHospira, Inc.2005-11-02341
K052052HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ Hospira, Inc.2005-08-242610
K043256HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARHospira, Inc.2004-12-06123
K042980HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECHospira, Inc.2004-11-17192
K042800LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.2004-10-18102
K042609HOSPIRA MEDNET MEDICATION MANAGEMENT SUITEHospira, Inc.2004-10-06121
K042081PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PHospira, Inc.2004-08-242119

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda