510(k) Report

FDA applicant

Omni-Flow, Inc.

Wilmington, MA1 decision1988–19884 recalls

FDA records 1 decision for Omni-Flow, Inc. (Wilmington, MA) in 1988: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Omni-Flow, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omni-Flow, Inc. since 2007.

Recalls per year

4in 2009

2009: 4
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Omni-Flow, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRNPump, Infusion1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K882594The Omni-Flow Therapist Infusion Management SystemOmni-Flow, Inc. · 19881cites it

What has FDA decided for it lately?

  • K882594The Omni-Flow Therapist Infusion Management SystemOmni-Flow, Inc. · 19884 recalls

The one decision as Omni-Flow, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K882594ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with…Nov 24, 2009
  • K882594ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with…Nov 24, 2009
  • K882594ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Green…Nov 24, 2009
  • K882594Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07, 40051-04-09, 40051-04-51; AC…Aug 11, 2009

Other applicant names beginning “Omni-Flow”

FDA records each applicant name separately; these may or may not be the same firm.

Omni Life Science, Inc. 21Omni Intl., Inc. 12Omni Hearing Systems 7Omni Therm, Inc. 5Omni-Tract Surgical, Div. Minn. Scientific, Inc. 4Omni Surgical, L.P. 2Omni-Guide Holdings, Inc. 2Omni Sales Corp. 2Omni Mfg., Inc. 1Omni Medical Designs 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1