510(k) · Cleared
ClearedFluid Level Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coleman Laboratories · FLN Monitor, Electric For Gravity Flow Infusion Systems
Cleared on Apr 24, 2014 as substantially equivalent to K030136 (Drip Alert, Inc., 2003) and 1 other predicate after a 125-day review. Its family tree reaches back 3 generations to 2000. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 24, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- FLN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002211 (2000). 7 ancestors in all, the oldest K903193 (1990). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
- 2 generations backK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
- 1 generation backK030136 Drip AlertDrip Alert, Inc. · 2003
- This deviceK133870 Fluid Level MonitorColeman Laboratories · 2014
Class I recalls in this family
- K012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition…2 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | 4 |
| −2 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| −1 | K030136 | Drip Alert | Drip Alert, Inc. | 2003 | — |
| 0 (this device) | K133870 | Fluid Level Monitor | Coleman Laboratories | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K030136 | Drip AlertSummary page 1…itor for gravity flow infusion systems Product Code: FLN 510O(k) INumber: K133870 3) Predicate Device 510(k) Number: K0301 36,1K903193 Trade Name: Drip Alert, Leveledt Product Code: FLN 4) Description of Device… | 2003 |
| * | K903193 | Smith & Nephew Dyonics Levelert SystemSummary page 1…ravity flow infusion systems Product Code: FLN 510O(k) INumber: K133870 3) Predicate Device 510(k) Number: K0301 36,1K903193 Trade Name: Drip Alert, Leveledt Product Code: FLN 4) Description of Device Fluid Lev… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K030136.
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. 2014, 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 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133870: Fluid Level Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133870
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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