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PreOp v3

by Clouds of Care

510(k) K252565

PreOp v3 is a Class II device made by Clouds of Care, cleared under FDA 510(k) K252565 on 13 Feb 2026, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK252565 Date13 Feb 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OLX
Device class
Class II
Regulation
21 CFR Part 882.1400
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

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

Other devices from Clouds of Care