Hospira Sapphire Sets
FDA 510(k) K160492 · Hospira, Inc.
510(k) numberK160492
Submission
- Device name
- Hospira Sapphire Sets
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- February 22, 2016
- Decision date
- December 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K190013 | WellDoc BlueStarMRZ · Traditional | Welldoc, Inc. | 11/04/2019SE |
| K173531 | Lockbox for Perfusor Space PCA Infusion PumpMRZ · Traditional | B.Braun Medical, Inc. | 08/02/2018SE |
| K171346 | Sapphire SetsMRZ · Traditional | Icu Medical | 08/25/2017SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | Welldoc, Inc. | 01/12/2017SE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ · Traditional | Welldoc, Inc. | 11/22/2016SE |
More from Welldoc, 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 |
| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| 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 Sapphire Sets cleared by the FDA?
Hospira Sapphire Sets (K160492) received a 510(k) decision of Substantially Equivalent on December 6, 2016, 288 days after the submission was received.
What is the product code of K160492?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.