510(k) · Cleared
ClearedVital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 14, 2012 as substantially equivalent to K102835 (Edan Instruments, Inc., 2010) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 2010. 2 later devices descend from it.
- Decided
- Feb 14, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K102835 (2010). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK102835 Vital Signs MonitorEdan Instruments, Inc. · 2010
- This deviceK120144 Vital Signs MonitorEdan Instruments, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK131818 Vital Signs MonitorEdan Instruments, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK180380 vital signs monitorEdan Instruments, Inc. · 2018 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102835 | Vital Signs Monitor | Edan Instruments, Inc. | 2010 | — |
| 0 (this device) | K120144 | Vital Signs Monitor | Edan Instruments, Inc. | 2012 | — |
| +1 | K131818 | Vital Signs Monitor | Edan Instruments, Inc. | 2013 | 2 |
| +2 | K180380 | vital signs monitor | Edan Instruments, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 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.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K102835 | Vital Signs MonitorSummary page 1…Manufacturer Predicate Device 510(k) # EDAN INSTRUMENTS, INC. M3,M3A K102835 RADIANT INNOVATION, INC. THP59J K111637 Device Description: M3 a… | 2010 |
| * | K111637 | Infrared Ear ThermometerSummary page 1…EDAN INSTRUMENTS, INC. M3,M3A K102835 RADIANT INNOVATION, INC. THP59J K111637 Device Description: M3 and M3A Vital Signs Monitor is a patient monitoring device providing the… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131818 | Vital Signs Monitor | 2013 | 1 |
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?
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO 2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).
The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.
The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120144: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120144
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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