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Optistar MR Injector System

by Mallinckrodt Inc., Liebel-Flarsheim Business

510(k) K984088

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK984088 Date6 Dec 1999ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1118-2012 FDA Not yet classified initiated 10 Feb 2012
    • Terminated Z-1119-2012 FDA Not yet classified initiated 10 Feb 2012
    • Terminated Z-1120-2012 FDA Not yet classified initiated 10 Feb 2012
    • Terminated Z-1121-2012 FDA Not yet classified initiated 10 Feb 2012
    • Terminated Z-1122-2012 FDA Not yet classified initiated 10 Feb 2012

    The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.

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  • Withdrawn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
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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