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Harvard 1 Syringe Pump/Harvard 1 with Pca Syringe Pump

by Harvard Clinical Technology

510(k) K033054

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033054 Date16 Dec 2003ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0433-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004
    • Terminated Z-0432-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Potential pump motor/encoder assembly failure may cause over infusing medication in patients

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  • Withdrawn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
MEA
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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