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ForeSight FSESM

by Edwards Lifesciences LLC

Ref FSESM

ForeSight FSESM is a device classified as Class IIa in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0690103D001FSS000W7), cleared under FDA 510(k) K143675 on 10 Apr 2015 and listed in FDA GUDID since 26 Aug 2024 (UDI-DI 00690103211337), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143675

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001FSS000W7 Basic UDI-DI 00690103211337UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103211337 UDI-DI Date26 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143675 Date10 Apr 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001FSS000W7 registered 1 Oct 2026 Active
  • FDA 510(k) K143675 decided 10 Apr 2015 Active
  • FDA GUDID UDI-DI 00690103211337 listed 26 Aug 2024 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

4 dated events

  1. Cleared FDA 510(k) K143675
  2. Recall initiated FDA recalls Z-0834-2022
  3. Listed FDA GUDID 00690103211337
  4. Registered EUDAMED 0690103D001FSS000W7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ForeSight
Generic name
Tissue saturation oximeter sensor, single-use
Device name
ForeSight sensors
Model / Ref / Catalog
FSESM
Primary DI / UDI-DI
00690103211337
Basic UDI-DI
0690103D001FSS000W7
510(k) Number
FDA product code
MUD
EMDN code
Z12030285 Vital signs monitoring instruments - consumables
GMDN term
Tissue saturation oximeter sensor, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Tissue saturation oximeter sensor, single-use

Cleared under the same submission (K143675)

and 8 more cleared under K143675

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)