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Vacutainer Plus with Hemogard Closure

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K901449

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK901449 Date9 Aug 1990ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2299-2019 FDA Class II initiated 12 Jun 2019
    • Terminated Z-2298-2019 FDA Class II initiated 12 Jun 2019
    • Terminated Z-2296-2019 FDA Class II initiated 12 Jun 2019
    • Terminated Z-2310-2019 FDA Class II initiated 12 Jun 2019
    • Terminated Z-2297-2019 FDA Class II initiated 12 Jun 2019
    • Terminated Z-2309-2019 FDA Class II initiated 12 Jun 2019

    False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

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  • Withdrawn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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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