510(k) · Cleared
ClearedLevelert II Fluid Level Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · FLN Monitor, Electric For Gravity Flow Infusion Systems
Cleared on Feb 14, 2006 as substantially equivalent to K912453 (Smith & Nephew Dyonics, Inc., 1991) after a 27-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Feb 14, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- FLN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912453 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912453 Intelijet TM Fluid Management SystemSmith & Nephew Dyonics, Inc. · 1991
- This deviceK060123 Levelert II Fluid Level SensorSmith & Nephew, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912453 | Intelijet TM Fluid Management System | Smith & Nephew Dyonics, Inc. | 1991 | — |
| 0 (this device) | K060123 | Levelert II Fluid Level Sensor | Smith & Nephew, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K912453 | Intelijet TM Fluid Management SystemSummary page 1…c for Gravity Flow Infusion Systems D. Predicate Devices The predicate device for the Levelert II is the current Smith & Nephew Dyonics Levelert System cleared in K912453. E. Description of Device The Levelert II is a irrigation fluid bag level sensing device designed to provide the use… | 1991 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K912453.
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?
The Smith & Nephew LEVELERT 11 Fluid Level Sensor is intended to weigh a bag of irrigation fluid and signal operating room personnel when a pre-determined amount of fluid remains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060123 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060123: Levelert II Fluid Level Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060123
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026