# K092491: Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill Sizes

- Pathway: 510(k) (Traditional)
- Applicant: Medefil, Inc.
- Decided: Feb 3, 2010 after 174 days
- Product code: NZW (Heparin, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993518 (2000). 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)
- 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 2.

## Recalls of this device
- Feb 19, 2014 · Class III · Z-1149-2014: The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a
- Nov 1, 2010 · Not classified · Z-0599-2011: The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
- Nov 1, 2010 · Not classified · Z-0600-2011: The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
- Nov 1, 2010 · Not classified · Z-0601-2011: The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).

## Indications for use
FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

Source page: https://510kreport.com/device/K092491
Methodology: https://510kreport.com/methodology