# Hospira, Inc.

- Location (FDA's records): Lake Forest, IL
- FDA decisions: 46 (1989–2017): 45 510(k) clearances and 1 original PMA approval
- Product codes: FPA (14), FRN (12), DQE (5), MEA (3), DRS (2), QBP (1), LHI (1), DRG (1), IQG (1), KPE (1), MRZ (1), KNT (1)
- 510(k) review time since 2016: median 268 days, against 240 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 89 (46 its own); citations of its devices by later devices: 72 (46 its own)
- Recalls linked to its devices: 351 (29 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 25 (https://510kreport.com/company/abbott-laboratories)
- Oximetrix, Inc.: 4 (https://510kreport.com/company/oximetrix)
- Edwards Lifesciences, LLC: 3 (https://510kreport.com/company/edwards-lifesciences)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Gmp/Companies, Inc.: 1 (https://510kreport.com/company/gmp-companies)
- Sterling Drug, Inc.: 1 (https://510kreport.com/company/sterling-drug)
- Q Core Medical, Ltd.: 1 (https://510kreport.com/company/q-core-medical)
- Iv Medical, Inc.: 1 (https://510kreport.com/company/iv-medical)

## Firms that cite its devices most
- Icu Medical, Inc.: 5 (https://510kreport.com/company/icu-medical)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Elcam Medical Acal: 2 (https://510kreport.com/company/elcam-medical-acal)
- Urogen Pharma, Ltd.: 1 (https://510kreport.com/company/urogen-pharma)
- Q Core Medical, Ltd.: 1 (https://510kreport.com/company/q-core-medical)
- Healthwatch, Ltd.: 1 (https://510kreport.com/company/healthwatch)
- Biometrix, Ltd.: 1 (https://510kreport.com/company/biometrix)
- Excelsior Medical Corp.: 1 (https://510kreport.com/company/excelsior-medical)

## Its most-cited devices
- K101677: Hospira Infusion Blood Sets (2010), cited by 8
- K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software (2004), cited by 6
- K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit (2006), cited by 5
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal (2012), cited by 5
- K052722: Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others (2005), cited by 4
- K142974: Extension Sets (2015), cited by 3

## Recent decisions
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (Mar 28, 2017)
- K161036: Hospira Extension Set, Hospira Primary Set (Jan 6, 2017)
- K160492: Hospira Sapphire Sets (Dec 6, 2016)
- K160870: Hospira Administration Sets (Jun 1, 2016)
- K143612: LifeCare PCA Infusion System (Apr 8, 2016)
- K143087: Hospira Blood Set (Mar 4, 2015)
- K143015: Hospira Primary Sets (Feb 25, 2015)
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (Jan 16, 2015)

Source page: https://510kreport.com/company/hospira