# K023740: Syrex Pre-Filled Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corp.
- Decided: May 13, 2003 after 187 days
- Product code: NZW (Heparin, Vascular Access Flush)
- 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082689: Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule (2009), 1 descendant of its own
- K133446: Heparin Lock / Flush Syringes (2014), 0 descendants of its own
- K103740: Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule (2011), 0 descendants of its own

## Recalls of this device
- Apr 28, 2016 · Class II · Z-1989-2016: Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.

## Indications for use
Flushing of IV catheters and IV tubing only. Prior to andafter administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 UnitslmL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. lbis device is not to be used for anticoagulant therapy. Protect from freezing and avoid excessive heat. Store at 25°C (77° F); excursions permitted to 15° - 30°C (59°-86°F)

Source page: https://510kreport.com/device/K023740
Methodology: https://510kreport.com/methodology