# K013121: MT Alert Infusion Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sierra Biosearch, Inc.
- Decided: Oct 15, 2001 after 27 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. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Dyonics LeveLert System: named in the summary without a submission number

## Indications for use
MT Alert Infusion Monitor is intended for use in any healthcare setting where gravity-flow infusions are utilized. The device monitors the weight of the infusion bag and sounds an audible alarm to alert users of various gravity infusion end-points. These end-points include (1) near-empty condition and (2) fluid bolus completion.. Current practice typically involves visual monitoring of infusion bags by healthcare personnel for near-empty condition and for fluid bolus completion. Although the MT Alert Infusion Monitor in no way affects the safe use of a gravity IV, it can improve efficiency within a busy medical setting by notifying healthcare personnel of gravity infusion end-points. This alert system allows for timely replacement of intravenous or irrigation bags and prompts healthcare providers to reevaluate the infusion rate at the completion of a 250 or 500ml fluid bolus.

Source page: https://510kreport.com/device/K013121
Methodology: https://510kreport.com/methodology