# K133446: Heparin Lock / Flush Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corporation
- Decided: Nov 14, 2014 after 367 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
Longest line of descent: 1 generation back to K023740 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023740: Syrex Pre-Filled Syringe, Excelsior Medical Corp. (2003) Summary page 4.
- K061497: Syrex Heparin Lock Flush Syringe, 1 Unit/ML & 2 Units/ML, Excelsior Medical Corp. (2007) Summary page 4.

## Recalls of this device
- May 25, 2022 · Class II · Z-1596-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy. Heparin Lock Flush, USP is supplied as: • 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe • 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume in a 10 mL syringe • 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe • 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe • 300 USP Units per 3 mL (100 USP unit per mL); 3 mL volume in a 10 mL syringe • 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 10 mL syringe

Source page: https://510kreport.com/device/K133446
Methodology: https://510kreport.com/methodology