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PreOp v2

by Clouds of Care

PreOp v2 is a Class II device made by Clouds of Care, cleared under FDA 510(k) K172858 on 8 Jan 2018 and listed in FDA GUDID since 22 Jun 2022 (UDI-DI 05430000733021), 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) K172858

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 Number05430000733021 UDI-DI Date22 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172858 Date8 Jan 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172858 decided 8 Jan 2018 Active
  • FDA GUDID UDI-DI 05430000733021 listed 22 Jun 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172858
  2. Listed FDA GUDID 05430000733021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PreOp
Generic name
Bioelectrical signal analysis software
Model / reference
v2
Primary DI / UDI-DI
05430000733021
510(k) Number
FDA product code
OLX
GMDN term
Bioelectrical signal analysis software
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bioelectrical signal analysis software

Cleared under the same submission (K172858)

Similar devices

Other devices filed under FDA product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph).

Other devices from Clouds of Care

Properties

  • Prescription use
Other properties (14, all answered No)