# K032417: Heparin Lock Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Am2 Pat, Inc.
- Decided: Dec 23, 2003 after 140 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952645 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002142: Saline IV Flush Syringe, Emt-Rx (2002) Summary page 1.
- K011967: BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe, Bd (2002)
- K003245: Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp Units/ML, Baxter Healthcare Corp (2000) Summary page 1.
- K020996: Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL, Medefil, Inc. (2002) Summary page 1.

## Recalls of this device
- Dec 11, 2007 · Not classified · Z-0827-2008: Lack of assurance of sterility by manufacturer

## Indications for use
The Heparin Flush Syringe, 10 and 100 units/mL is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Source page: https://510kreport.com/device/K032417
Methodology: https://510kreport.com/methodology