# K091583: Medefil's Normal Saline I.V. Flush Syringe

- Pathway: 510(k) (Special)
- Applicant: Medefil, Inc.
- Decided: Jan 28, 2010 after 240 days
- Product code: NGT (Saline, 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: 2 generations back to K993515 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020999: Medefil's Normal Saline 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.

## Most influential descendants
- K121262: Medeflush Normal Saline I.V. Flush Syringe-Sterile Field Ready (2012), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1619-2022: 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
FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

Source page: https://510kreport.com/device/K091583
Methodology: https://510kreport.com/methodology