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Fore-Sight® 01-07-1003

by Cas Medical Systems, Inc.

Fore-Sight® 01-07-1003 is a Class II device made by Cas Medical Systems, Inc., cleared under FDA 510(k) K112820 on 26 Jan 2012 and listed in FDA GUDID since 6 Mar 2017 (UDI-DI 10609538710039), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K112820

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10609538710039 UDI-DI Date6 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112820 Date26 Jan 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112820 decided 26 Jan 2012 Active
  • FDA GUDID UDI-DI 10609538710039 listed 6 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112820
  2. Listed FDA GUDID 10609538710039

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fore-Sight®
Generic name
Tissue saturation oximeter sensor, single-use
Model / reference
01-07-1003
Primary DI / UDI-DI
10609538710039
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
Size
Length — 2.5 Centimeter

Similar devices in this category

Other devices filed under Tissue saturation oximeter sensor, single-use.

Other devices from Cas Medical Systems, Inc.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)