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Hemosphere Foresight Module HEMFSM10

by Edwards Lifesciences LLC

Part of a family of 18 devices: see the family page

Ref HEMFSM10

Hemosphere Foresight Module HEMFSM10 is a device classified as Class IIb in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI 0690103D001HAM000PH), cleared under FDA 510(k) K213682 on 22 Jun 2022 (1 earlier submission) and listed in FDA GUDID since 17 Aug 2020 (UDI-DI 00690103208573), active as of 24 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) K213682

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001HAM000PH Basic UDI-DI 00690103208573UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213682 Date22 Jun 2022DecidedStatusActive
United StatesGUDID listing GUDID Number00690103208573 UDI-DI Date17 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001HAM000PH registered 5 Aug 2026 Active
  • FDA 510(k) K213682 decided 22 Jun 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103208573 listed 17 Aug 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0835-2022 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

5 dated events

  1. Cleared FDA 510(k) K180003
  2. Listed FDA GUDID 00690103208573
  3. Recall initiated FDA recalls Z-0835-2022
  4. Cleared FDA 510(k) K213682
  5. Registered EUDAMED 0690103D001HAM000PH

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 EUDAMED
Hemosphere Foresight Module GUDID
Generic name
Tissue saturation oximeter
Device name
HemoSphere Advanced Monitoring Platform
Model / Ref / Catalog
HEMFSM10
Primary DI / UDI-DI
00690103208573
Basic UDI-DI
0690103D001HAM000PH
510(k) Number
FDA product code
MUD, DQK, DQE, QAQ, DXN, DSB, QMS, FLL
EMDN code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN term
Tissue saturation oximeter
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700, 870.1425, 870.1230, 870.2210, 870.1130, 870.2770, 870.5600, 880.2910
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: General-purpose multi-parameter bedside monitorTissue saturation oximeter

Cleared under the same submission (K180003)

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)