# K003520: Nexan System, Model NX-300

- Pathway: 510(k) (Special)
- Applicant: Nexan, Ltd.
- Decided: Dec 13, 2000 after 28 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
100 later devices descend from it; 2 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061993: Equivital, Model EQ-01 (2006), 99 descendants of its own
- K113054: Equivital (2012), 71 descendants of its own
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library) (2014), 70 descendants of its own
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), 43 descendants of its own
- K081140: Visensia (2008), 22 descendants of its own

Source page: https://510kreport.com/device/K003520
Methodology: https://510kreport.com/methodology