Hospira Administration Sets
FDA 510(k) K160870 · Hospira, Inc.
510(k) numberK160870
Submission
- Device name
- Hospira Administration Sets
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- March 30, 2016
- Decision date
- June 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleFRN · Traditional | 03/28/2017SE |
| K161036 | Hospira Extension Set, Hospira Primary SetFPA · Traditional | 01/06/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | 12/06/2016SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | 04/08/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
| K142433 | Hospira Extension SetFPA · Traditional | 12/08/2014SE |
Questions and answers
When was Hospira Administration Sets cleared by the FDA?
Hospira Administration Sets (K160870) received a 510(k) decision of Substantially Equivalent on June 1, 2016, 63 days after the submission was received.
What is the product code of K160870?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.