# K993515: Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6 ML Syringe L

- Pathway: 510(k) (Traditional)
- Applicant: Medefil, Inc.
- Decided: Feb 25, 2000 after 130 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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 (2002), 2 descendants of its own
- K091583: Medefil's Normal Saline I.V. Flush Syringe (2010), 1 descendant of its own
- K121262: Medeflush Normal Saline I.V. Flush Syringe-Sterile Field Ready (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K993515
Methodology: https://510kreport.com/methodology