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Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360; Medstar 370, Model 533-370

by Cibernet Systems Corp.

510(k) K050951

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK050951 Date19 Jul 2005ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0855-2010 FDA Unclassified (pre-2012) initiated 23 Jan 2008
    • Terminated Z-0854-2010 FDA Unclassified (pre-2012) initiated 23 Jan 2008
    • Terminated Z-0852-2010 FDA Unclassified (pre-2012) initiated 23 Jan 2008
    • Terminated Z-0853-2010 FDA Unclassified (pre-2012) initiated 23 Jan 2008

    A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.

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  • Withdrawn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
DXH
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent