Endeavour Monitoring System

510(k) K102004

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK102004	Date10 Sep 2010Cleared	StatusActive

3 recalls · FDA

- Terminated Z-0389-2014 FDA Class II initiated 7 Oct 2013
Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.
- Terminated Z-0528-2013 FDA Class II initiated 24 Sep 2012
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
- Terminated Z-2279-2012 FDA Class II initiated 7 May 2012
Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.

1 jurisdiction

United States — FDA 510(k) Active

510(k)