# K161552: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Feb 2, 2017 after 241 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003553 (2001). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141311: 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe, Becton, Dickinson and Company (2014) Summary page 4.

## Most influential descendants
- K250884: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (2025), 0 descendants of its own
- K213955: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub (2022), 0 descendants of its own

## Recalls of this device
- Nov 16, 2023 · Class II · Z-0736-2024: An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes 
- Oct 14, 2019 · Class II · Z-0499-2020: Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
- Oct 14, 2019 · Class II · Z-0500-2020: Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

## Indications for use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.

Source page: https://510kreport.com/device/K161552
Methodology: https://510kreport.com/methodology