EV1000 EV1000M
EV1000 EV1000M is a Class II device made by Edwards Lifesciences LLC, cleared under FDA 510(k) K160552 on 1 Jun 2016 (2 earlier submissions) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103190106), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00690103190106 | Date3 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160552 | Date1 Jun 2016 | StatusActive |
Official records
- AccessGUDID record 00690103190106
- FDA 510(k) database K160552
- FDA 510(k) database K140312
- FDA 510(k) database K131892
Across registries
- FDA 510(k) K160552 decided 1 Jun 2016 Active
- FDA GUDID UDI-DI 00690103190106 listed 3 Sep 2016 Listed
Recalls
-
- Terminated Z-1193-2019
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
-
- Terminated Z-1732-2015
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
Timeline
- Cleared FDA 510(k) K131892
- Cleared FDA 510(k) K140312
- Recall initiated FDA recalls Z-1732-2015
- Cleared FDA 510(k) K160552
- Listed FDA GUDID 00690103190106
- Recall initiated FDA recalls Z-1193-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EV1000
- Generic name
- Patient monitoring system module, blood pressure, noninvasive
- Model / Ref / Catalog
- EV1000M
- Primary DI / UDI-DI
- 00690103190106
- FDA product code
- DSB, DXN, DXG
- GMDN term
- Patient monitoring system module, blood pressure, noninvasive
- Device class
- Class II
- Regulation number
- 870.2770, 870.1130, 870.1435
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Patient positioning sensor.