# K133870: Fluid Level Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Coleman Laboratories
- Decided: Apr 24, 2014 after 125 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
Longest line of descent: 3 generations back to K002211 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030136: Drip Alert, Drip Alert, Inc. (2003) Summary page 1.
- K903193: Smith & Nephew Dyonics Levelert System, Smith & Nephew Dyonics, Inc. (1990) Summary page 1.

## Indications for use
The Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid is low. The device provides both visual and audible alarms when preset condition is met. The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare selling where gravity flow infusion is utilized. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of timely notification of the low-fluid-level status. LM771: I1-channel, DC bat'ery power LM781I: I -channel, DC plug-in power LM785: 5-channel DC plug-in power

Source page: https://510kreport.com/device/K133870
Methodology: https://510kreport.com/methodology