# K153481: 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Apr 4, 2016 after 123 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003553 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121050: 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe, Becton, Dickinson & CO (2013) Summary page 4.

## Most influential descendants
- K231161: 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (2023), 0 descendants of its own

## Recalls of this device
- Apr 16, 2020 · Class II · Z-2065-2020: This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

## Indications for use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.

Source page: https://510kreport.com/device/K153481
Methodology: https://510kreport.com/methodology