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The Imed Ambulatory Infusion Pump, Administration Sets

by Imed Corp.

510(k) K953896

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK953896 Date20 Mar 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1445-06 FDA Unclassified (pre-2012) initiated 29 Mar 2006

    Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.

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  • Withdrawn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

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