510(k) · Cleared
ClearedLow Fluid Alarm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Em-Tec GmbH · FLN Monitor, Electric For Gravity Flow Infusion Systems
Cleared on Apr 17, 2008 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 17, 2008
- Review
- 36 days
- Class
- Class II
- Product code
- FLN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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. 2008, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080704 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080704: Low Fluid Alarm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080704
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026