# K952645: Vital Signs Saline Vascular Access Flush Device

- Pathway: 510(k) (Traditional)
- Applicant: Vital Signs, Inc.
- Decided: Dec 13, 1995 after 187 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K982558: BD Preefile Normal Saline Flush Syringe Flush Syringe (2000), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K952645
Methodology: https://510kreport.com/methodology