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ForeSight FSESM

by Becton, Dickinson and Company

ForeSight FSESM is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K143675 on 10 Apr 2015 and listed in FDA GUDID since 14 Sep 2026 (UDI-DI 00885403530923), active as of 26 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 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885403530923 UDI-DI Date14 Sep 2026ListedStatusListed 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 00885403530923 listed 14 Sep 2026 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. Recall initiated FDA recalls Z-0834-2022
  3. Listed FDA GUDID 00885403530923

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ForeSight
Generic name
Tissue saturation oximeter sensor, single-use
Model / Ref / Catalog
FSESM
Primary DI / UDI-DI
00885403530923
510(k) Number
FDA product code
MUD
GMDN term
Tissue saturation oximeter sensor, single-use
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K143675)

and 8 more cleared under K143675

Similar devices

Other devices filed under FDA product code MUD (Oximeter, tissue saturation).

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)