510(k) Report

FDA applicant

Omni-Glow, Inc.

Mchenry, IL1 decision1983–198316 recalls

FDA records 1 decision for Omni-Glow, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 16 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-Glow, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

9in 2009

2009: 9
2007high 9 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Omni-Glow, 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.

  • K832755Infusion Pump & IV Sets #4000Omni-Glow, Inc. · 19831cites it

What has FDA decided for it lately?

  • K832755Infusion Pump & IV Sets #4000Omni-Glow, Inc. · 198316 recalls

The one decision as Omni-Glow, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K832755Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and…Nov 24, 2009
  • K832755Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line…Nov 24, 2009
  • K832755Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and…Nov 24, 2009
  • K832755Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and…Nov 24, 2009
  • K832755Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and…Nov 24, 2009
  • K832755Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line…Nov 24, 2009

Other applicant names beginning “Omni-Glow”

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-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1