# K121050: 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 7, 2013 after 307 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: 2 generations back to K003553 (2001). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003553: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (2001) Summary page 1.
- K042061: 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe, Becton Dickinson (2004) Summary page 1.

## Most influential descendants
- K141311: 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe (2014), 3 descendants of its own
- K161552: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (2017), 2 descendants of its own
- K153481: 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe (2016), 1 descendant of its own
- K250884: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (2025), 0 descendants of its own
- K231161: 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (2023), 0 descendants of its own

## Recalls of this device
- Jul 22, 2014 · Class II · Z-2673-2014: BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).

## Indications for use
BD PosiFlushm Normal Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. Catalog No. 306547 10mL BD PcsiFlushm Normal Saline Flush Syringes are generally compatible for use with syringe PUMPS.

Source page: https://510kreport.com/device/K121050
Methodology: https://510kreport.com/methodology