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The Omni-Flow Therapist Infusion Management System

by Omni-Flow, Inc.

510(k) K882594

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK882594 Date20 Sep 1988ClearedStatusActive

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1344-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K882594
    • Terminated Z-1342-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K882594
    • Terminated Z-1343-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K882594

    Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

    • Terminated Z-0020-2010 FDA Unclassified (pre-2012) initiated 11 Aug 2009

    Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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