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Multilab 2000

by Unetixs, Inc.

510(k) K904392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904392 Date29 Apr 1991ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1196-2023 FDA Class II initiated 10 Feb 2023
    • Ongoing Z-1194-2023 FDA Class II initiated 10 Feb 2023
    • Ongoing Z-1195-2023 FDA Class II initiated 10 Feb 2023
    • Ongoing Z-1193-2023 FDA Class II initiated 10 Feb 2023

    The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.

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  • Withdrawn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
JAF
Device Class
Class II
Regulation
21 CFR Part 892.1540
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent