510(k) · Cleared
Recalled · Class II · 2025Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DQA Oximeter
Cleared on Aug 30, 2013 as substantially equivalent to K120144 (Edan Instruments, Inc., 2012) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 2010. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 30, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K102835 (2010). 4 ancestors in all, the oldest K003313 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK102835 Vital Signs MonitorEdan Instruments, Inc. · 2010
- 1 generation backK120144 Vital Signs MonitorEdan Instruments, Inc. · 2012
- This deviceK131818 Vital Signs MonitorEdan Instruments, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180380 vital signs monitorEdan Instruments, Inc. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K180380vital signs monitorEdan Instruments, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K102835 | Vital Signs Monitor | Edan Instruments, Inc. | 2010 | — |
| −1 | K120144 | Vital Signs Monitor | Edan Instruments, Inc. | 2012 | — |
| 0 (this device) | K131818 | Vital Signs Monitor | Edan Instruments, Inc. | 2013 | — |
| +1 | K180380 | vital signs monitor | Edan Instruments, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K120144 | Vital Signs MonitorSummary page 1…OQA, DXN, FLL Classification: Class 11 3. Predicate Devices: " Edan Instruments Inc.: M3 and M3A Vital Signs Monitor K120144 " The Kendall Company: K003313 4. Device Description: The Vital Signs Monitor is a portable device… | 2012 |
| * | K003313 | Filac Fas Temp Electronic ThermometerSummary page 1…. Predicate Devices: " Edan Instruments Inc.: M3 and M3A Vital Signs Monitor K120144 " The Kendall Company: K003313 4. Device Description: The Vital Signs Monitor is a portable device intended for use by health care… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180380 | vital signs monitor | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2025 | Class II | Z-1142-2026 | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| Oct 24, 2025 | Class II | Z-1153-2026 | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180380 (Edan Instruments, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 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 Sp0 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/K131818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131818: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131818
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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