FDA applicant

Hospira, Inc.

Lake Forest, IL46 decisions1989–2017351 recalls

FDA records 46 decisions for Hospira, Inc. (Lake Forest, IL) from 1989 to 2017: 45 510(k) clearances and 1 original PMA approval. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Since 2016 its 510(k)s took a median of 268 days from receipt to decision, against 240 for FDA’s reviews in the same codes and years. Its devices cite 89 predicates, 46 of them its own earlier devices. 351 recalls are linked to its devices, 29 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Hospira, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2007high 5 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2026

2007high 188 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hospira, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hospira, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

FPASet, Administration, Intravascular14decisions
FRNPump, Infusion12decisions
DQECatheter, Oximeter, Fiber-Optic5decisions
MEAPump, Infusion, Pca3decisions
DRSTransducer, Blood-Pressure, Extravascular2decisions
QBPCap, Device Disinfectant1decision

Also: LHI (1), DRG (1), IQG (1), KPE (1), MRZ (1), KNT (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 268 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 240 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 89 predicates; 46 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 72 times; 46 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K101677Hospira Infusion Blood SetsHospira, Inc. · 20108cite it
K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 20046cite it
K061573Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 20065cite it
K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 20125cite it
K052722Lifeshield Latex-Free Microbore Extension Set, Model 14949 and OthersHospira, Inc. · 20054cite it
K142974Extension SetsHospira, Inc. · 20153cite it

What has FDA decided for it lately?

K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 20172 Class I recalls
K161036Hospira Extension Set, Hospira Primary SetHospira, Inc. · 2017
K160492Hospira Sapphire SetsHospira, Inc. · 2016
K160870Hospira Administration SetsHospira, Inc. · 2016
K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016
K143087Hospira Blood SetHospira, Inc. · 2015
K143015Hospira Primary SetsHospira, Inc. · 2015
K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 20152 Class I recalls

All 46 as Hospira, Inc. →

What has been recalled?

351 recalls linked to its devices; the latest:

K081361IV Sets with drip chambersMay 12, 2026Class II
K141789IV Sets with drip chambersMay 12, 2026Class II
K042081Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3…May 7, 2024Class I
K042081Plum 360/A+ spare batteries. Item Number: SUB0000864.May 7, 2024Class I
K141789Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List…May 7, 2024Class I
K141789Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414…Jul 13, 2023Class II