Flush Syringe Filled with 0.9% Sodium Chloride
FDA 510(k) K090882 · Hospira, Inc.
510(k) numberK090882
Submission
- Device name
- Flush Syringe Filled with 0.9% Sodium Chloride
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- March 31, 2009
- Decision date
- April 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGT – Saline, Vascular Access Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Other 510(k)s with product code NGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP SyringeNGT · Traditional | Becton, Dickinson and Company | 12/02/2025SE |
| K233623 | Praxiject SP 0.9% NaClNGT · Traditional | Medxl, Inc. | 02/27/2024SE |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution)NGT · Traditional | Spm Medicare Pvt. , Ltd. | 11/09/2023SE |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)NGT · Traditional | Hantech Medical Device Co., Ltd. | 09/27/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/12/2023SE |
| K223584 | Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tianyang Pharmaceutical Co., Ltd. | 08/12/2023SE |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush SyringeNGT · Traditional | Becton, Dickinson and Company | 07/21/2023SE |
| K231754 | Praxiject 0.9% NaClNGT · Special | Medxl, Inc. | 07/13/2023SE |
| K214080 | PentaflushNGT · Traditional | Pentaferte Italia S.R.L. | 07/20/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Amsino International, Inc. | 03/22/2022SE |
More from Amsino International, 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 |
| 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 |
Questions and answers
When was Flush Syringe Filled with 0.9% Sodium Chloride cleared by the FDA?
Flush Syringe Filled with 0.9% Sodium Chloride (K090882) received a 510(k) decision of Substantially Equivalent on April 23, 2010, 388 days after the submission was received.
What is the product code of K090882?
The FDA product code is NGT – Saline, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.