# K011982: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe

- Pathway: 510(k) (Special)
- Applicant: Bd
- Decided: Jul 17, 2001 after 21 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
Longest line of descent: 2 generations back to K952645 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982558: BD Preefile Normal Saline Flush Syringe Flush Syringe, Bd/Preefil (2000) Summary page 1.

## Indications for use
The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD'S).

Source page: https://510kreport.com/device/K011982
Methodology: https://510kreport.com/methodology