# K080704: Low Fluid Alarm

- Pathway: 510(k) (Abbreviated)
- Applicant: Em-Tec GmbH
- Decided: Apr 17, 2008 after 36 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 Low Fluid Alarm System is a stand alone accessory for monitoring of liquid levels (standard saline solutions or other solutions with an aqueous base) in a reservoir. It is generally useable with rigid polycarbonate, flexible polyvinyl chloride (PVC) or glass reservoirs. If the level falls below a predetermined threshold visual and acoustical alarms appear. The Low Fluid Alarm System is designed for continuous arthroscopy operation in operating rooms and intensive care units. For the patient's safety the device is to be operated only by qualified medically-trained personnel and only with constant supervision.

Source page: https://510kreport.com/device/K080704
Methodology: https://510kreport.com/methodology