510(k) · Cleared
ClearedNexan System, Model NX-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexan, Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Dec 13, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 100 later devices descend from it.
- Decided
- Dec 13, 2000
- Review
- 28 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 0
100 later devices descend from it, 2 citing it directly.
- This deviceK003520 Nexan System, Model NX-300Nexan, Ltd. · 2000
- Descendant · cites it directly · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · cites it directly · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 2 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 3 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- Descendant · 2 generations on · 22 of its ownK081140 VisensiaObs Medical · 2008
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · cites it directly99descendants
- K113054EquivitalHidalgo Limited · 2012 · cites it directly71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 2 generations on70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 3 generations on43descendants
- K081140VisensiaObs Medical · 2008 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003520 | Nexan System, Model NX-300 | Nexan, Ltd. | 2000 | — |
| +1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +1 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +3 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| +2 | K081140 | Visensia | Obs Medical | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 15 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (100)
See all 1002 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061993 (Hidalgo Limited, 2006) has gone furthest, with 99 descendants of its own.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
https://510kreport.com/device/K003520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003520: Nexan System, Model NX-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003520
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026