# K970419: Daxor MAX100 Syringe (MAX100)

- Pathway: 510(k) (Traditional)
- Applicant: Daxor Corporation
- Decided: Dec 22, 1997 after 321 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly. This device will be used to inject into IV ports (not directly into the patient or into arterial lines).

Source page: https://510kreport.com/device/K970419
Methodology: https://510kreport.com/methodology