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Algo I

by Algotek, Inc.

510(k) K852687

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852687 Date18 Sep 1985ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0985-05 FDA Unclassified (pre-2012) initiated 27 Jun 2005 on shared 510(k) K852687

    Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
GWJ
Device Class
Class II
Regulation
21 CFR Part 882.1900
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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