# K121262: Medeflush Normal Saline I.V. Flush Syringe-Sterile Field Ready

- Pathway: 510(k) (Special)
- Applicant: Medefil, Inc.
- Decided: Sep 20, 2012 after 147 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993515 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091583: Medefil's Normal Saline I.V. Flush Syringe, Medefil, Inc. (2010) Summary page 2.

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

Source page: https://510kreport.com/device/K121262
Methodology: https://510kreport.com/methodology