510(k) · Cleared
ClearedMT Alert Infusion Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sierra Biosearch, Inc. · FLN Monitor, Electric For Gravity Flow Infusion Systems
Cleared on Oct 15, 2001 after a 27-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 15, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- FLN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Smith & Nephew Dyonics LeveLert System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FLN devicesFLN Monitor, Electric For Gravity Flow Infusion Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLN
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FLN
Too few FLN 510(k)s in any year since 2007 to give a median.
Recalls per year · FLN
No recall names FLN since 2007.
Adverse event reports per year · FLN
2in 2025
MAUDE reports naming product code FLN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (135 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013121: MT Alert Infusion Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013121
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026