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EV1000 EV1000DB

by Edwards Lifesciences LLC

EV1000 EV1000DB is a Class II device made by Edwards Lifesciences LLC, cleared under FDA 510(k) K160552 on 1 Jun 2016 (1 earlier submission) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103190113), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103190113 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160552 Date1 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160552 decided 1 Jun 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103190113 listed 3 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1193-2019 FDA Class I initiated 21 Mar 2019

    Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

Timeline

4 dated events

  1. Cleared FDA 510(k) K131892
  2. Cleared FDA 510(k) K160552
  3. Listed FDA GUDID 00690103190113
  4. Recall initiated FDA recalls Z-1193-2019

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EV1000
Generic name
General-purpose multi-parameter bedside monitor
Model / Ref / Catalog
EV1000DB
Primary DI / UDI-DI
00690103190113
510(k) Number
FDA product code
DXG, DXN, DSB
GMDN term
General-purpose multi-parameter bedside monitor
Device class
Class II
Regulation number
870.1435, 870.1130, 870.2770
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose multi-parameter bedside monitor

Cleared under the same submission (K131892)

and 8 more cleared under K131892

Cleared under the same submission (K160552)

and 8 more cleared under K160552

Similar devices in this category

Other devices filed under General-purpose multi-parameter bedside monitor.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)