# K003553: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Mar 21, 2001 after 124 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042061: 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush Syringe (2004), 7 descendants of its own
- K121050: 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush Syringe (2013), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K003553
Methodology: https://510kreport.com/methodology