# K982558: BD Preefile Normal Saline Flush Syringe Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd/Preefil
- Decided: Mar 8, 2000 after 595 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: 1 generation back to K952645 (1995). 1 ancestor in all.
5 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)
- K952645: Vital Signs Saline Vascular Access Flush Device, Vital Signs, Inc. (1995) Summary page 2.

## Most influential descendants
- K011967: BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe (2002), 3 descendants of its own
- K090680: Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe (2009), 1 descendant of its own
- K163591: BD PosiFlush Heparin Lock Flush Syringe (2017), 0 descendants of its own
- K032417: Heparin Lock Flush Syringe (2003), 0 descendants of its own
- K011982: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe (2001), 0 descendants of its own

## Indications for use
BD Prefill Normal Saline flush syringes are intended for the maintenance of the patency of vascular access devices.

Source page: https://510kreport.com/device/K982558
Methodology: https://510kreport.com/methodology