Hospira, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Hospira, Inc.” (first 2004, latest 2017), plus 1 PMA decision, across 15 product codes in 4 review panels. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 77 |
| 2013 | 1 | 113 |
| 2014 | 4 | 81 |
| 2015 | 5 | 128 |
| 2016 | 3 | 288 |
| 2017 | 2 | 286 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hospira, Inc. took a median 286 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 200 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 14 | 14 |
| FRN | Pump, Infusion | 12 | 12 |
| DQE | Catheter, Oximeter, Fiber-Optic | 5 | 5 |
| MEA | Pump, Infusion, Pca | 3 | 3 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| IQG | Adaptor, Holder, Syringe | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Plus 5 more product codes.
Review panels
- General Hospital (36)
- Cardiovascular (8)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Hospira, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | FRN | 2017-03-28 | 305 |
| K161036 | Hospira Extension Set, Hospira Primary Set | FPA | 2017-01-06 | 268 |
| K160492 | Hospira Sapphire Sets | MRZ | 2016-12-06 | 288 |
| K160870 | Hospira Administration Sets | FPA | 2016-06-01 | 63 |
| K143612 | LifeCare PCA Infusion System | MEA | 2016-04-08 | 476 |
| K143087 | Hospira Blood Set | FPA | 2015-03-04 | 128 |
| K143015 | Hospira Primary Sets | FPA | 2015-02-25 | 128 |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | FRN | 2015-01-16 | 198 |
| K142622 | IV Administration | FPA | 2015-01-15 | 121 |
| K142974 | Extension Sets | FPA | 2015-01-09 | 87 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880028 | PMA | DEXTRAN HM 32% | 1989-05-30 |
Recalls
290 product recalls in 78 recall events; 0 initiated in the last five years. Most recent: 2016-03-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hospira, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hospira, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Hospira, Inc.” (first 2004, latest 2017), plus 1 PMA decision, across 15 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hospira, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hospira, Inc. is 71 days.
Which FDA product codes appear under Hospira, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 14); FRN (Pump, Infusion, 12); DQE (Catheter, Oximeter, Fiber-Optic, 5).
Next steps
- See all 45 Hospira, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Hospira, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.