# K050783: Issys Drug Flow Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Sensing Systems, Inc.
- Decided: Feb 22, 2006 after 331 days
- Product code: FLN (Monitor, Electric For Gravity Flow Infusion Systems)
- Device class: 2
- Regulation: 21 CFR 880.2420
- 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
The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered. This monitor is indicated for use in cases where the flow rates are between 5 and 200 mL/hr. The accuracy of the monitor is +/- 20% at 5 mL/hr and +/- 5% at 200 mL/hr. For use with IV drug solutions administered by gravity. WARNING: DO NOT USE WITH BLOOD OR BLOOD PRODUCTS.

Source page: https://510kreport.com/device/K050783
Methodology: https://510kreport.com/methodology