# K011967: BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd
- Decided: Jan 23, 2002 after 212 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). 4 ancestors in all.
3 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)
- K953120: Vital Signs Heparin Vascular Access Flush Device, Vital Signs, Inc. (1995) Summary page 1.
- K982558: BD Preefile Normal Saline Flush Syringe Flush Syringe, Bd/Preefil (2000) Summary page 1.
- K003245: Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML, Baxter Healthcare Corp (2000) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD’S).

Source page: https://510kreport.com/device/K011967
Methodology: https://510kreport.com/methodology