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Foresight Elite FSEO2004

by Edwards Lifesciences LLC

Foresight Elite FSEO2004 is a Class II device made by Edwards Lifesciences LLC, cleared under FDA 510(k) K143675 on 10 Apr 2015 and listed in FDA GUDID since 10 Nov 2021 (UDI-DI 00690103208597), 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

1 ongoing

This device is named in the recall

Documents

510(k) K143675

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103208597 UDI-DI Date10 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143675 Date10 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143675 decided 10 Apr 2015 Active
  • FDA GUDID UDI-DI 00690103208597 listed 10 Nov 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0834-2022 FDA Class II initiated 1 Mar 2022

    The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

Timeline

3 dated events

  1. Cleared FDA 510(k) K143675
  2. Listed FDA GUDID 00690103208597
  3. Recall initiated FDA recalls Z-0834-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Foresight Elite
Generic name
Electrical-only medical device connection adaptor, reusable
Model / Ref / Catalog
FSEO2004
Primary DI / UDI-DI
00690103208597
510(k) Number
FDA product code
MUD
GMDN term
Electrical-only medical device connection adaptor, reusable
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
Size
Length — 4.0000 Meter

Related devices

Category: Electrical-only medical device connection adaptor, reusable

Cleared under the same submission (K143675)

and 8 more cleared under K143675

Similar devices in this category

Other devices filed under Electrical-only medical device connection adaptor, reusable.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)