BD PosiFlush Heparin Lock Flush Syringe
FDA 510(k) K163591 · Becton, Dickinson and Company
510(k) numberK163591
Submission
- Device name
- BD PosiFlush Heparin Lock Flush Syringe
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- December 20, 2016
- Decision date
- February 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NZW – Heparin, 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 NZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133446 | Heparin Lock / Flush SyringesNZW · Traditional | Excelsior Medical Corporation | 11/14/2014SE |
| K092938 | Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710NZW · Traditional | App Pharmaceuticals, LLC | 06/18/2010SE |
| K092491 | Medefil's Heparin I.V. Flush Syringe 1 Unit/Ml; 10 Units/Ml; and 100 Units/Ml in Various…NZW · Traditional | Medefil, Inc. | 02/03/2010SE |
| K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeNZW · Special | Becton, Dickinson & CO | 06/10/2009SE |
| K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/MlNZW · Traditional | Excelsior Medical Corp. | 02/23/2007SE |
| K023740 | Syrex Pre-Filled SyringeNZW · Traditional | Excelsior Medical Corp. | 05/13/2003SE |
More from Excelsior Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | 04/10/2026SE |
| K260184 | Onclarity Self-Collection KitSEP · Traditional | 04/02/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | 03/13/2026SE |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP SyringeNGT · Traditional | 12/02/2025SE |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…PCI · Traditional | 10/31/2025SE |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)ONB · Traditional | 09/12/2025SE |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional | 08/08/2025SE |
| K251350 | BD Plastipak SyringeFMF · Traditional | 07/29/2025SE |
Questions and answers
When was BD PosiFlush Heparin Lock Flush Syringe cleared by the FDA?
BD PosiFlush Heparin Lock Flush Syringe (K163591) received a 510(k) decision of Substantially Equivalent on February 27, 2017, 69 days after the submission was received.
What is the product code of K163591?
The FDA product code is NZW – Heparin, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.