510(k) Report

FDA applicant

Custom Medical Devices Intl., Inc.

Mchenry, IL3 decisions1980–19800 recalls

FDA records 3 decisions for Custom Medical Devices Intl., Inc. (Mchenry, IL) in 1980: 3 510(k) clearances. All are in product code FMG (Stopcock, I.V. Set). No recall is 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 Custom Medical Devices Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Custom Medical Devices Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Custom Medical Devices Intl., 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?

  • FMGStopcock, I.V. Set3decisions

What has FDA decided for it lately?

  • K800864Sterile Dispos. Plastic Stopcocks W/TubeCustom Medical Devices Intl., Inc. · 1980
  • K8008621,3 & 4 Way Sterile Dis. Plastic PKG.Custom Medical Devices Intl., Inc. · 1980
  • K800863Tandem Assembed 3&4 Way Sterile StopcksCustom Medical Devices Intl., Inc. · 1980

All 3 as Custom Medical Devices Intl., Inc. →

Other applicant names beginning “Custom”

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

Custom Pack Reliability 21Custom Spine, Inc. 14Custom Medical Products, Ltd. 14Custom Services Intl., Inc. 9Custom Orthopaedic Solutions, Inc. 8Custom Ultrasonics 6Custom Surgical Products, Inc. 4Custom Optical Frames, Inc. 4Custom Medical, Inc. 3Custom Cardio Components 2Custom Medical Plastics, Inc. 2Custom Hospitals Products 1