Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule
FDA 510(k) K103740 · Spectra Medical Devices, Inc.
510(k) numberK103740
Submission
- Device name
- Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule
- Applicant
- Spectra Medical Devices, Inc.
Washington, DC, US - Received
- December 22, 2010
- Decision date
- July 29, 2011
- 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 |
|---|---|---|
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordBSP · Traditional | 09/08/2017SE |
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleBSP · Traditional | 02/05/2016SE |
| K142791 | Spectra Soft Tissue Biopsy NeedlesKNW · Traditional | 01/21/2015SE |
| K082689 | Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, AmpuleNGT · Traditional | 03/20/2009SE |
| K082580 | Spectra Guidewire Introducer NeedleDYB · Traditional | 12/08/2008SE |
| K082674 | Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass…FMF · Traditional | 11/28/2008SE |
| K081524 | Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic…FMF · Traditional | 07/29/2008SE |
Questions and answers
When was Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule cleared by the FDA?
Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule (K103740) received a 510(k) decision of Substantially Equivalent on July 29, 2011, 219 days after the submission was received.
What is the product code of K103740?
The FDA product code is NGT – Saline, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.