FDA applicant

Custom Medical, Inc.

Mchenry, IL3 decisions1983–19910 recalls

FDA records 3 decisions for Custom Medical, Inc. (Mchenry, IL) from 1983 to 1991: 3 510(k) clearances. Most are in product codes FPK (Tubing, Fluid Delivery) and BTM (Ventilator, Emergency, Manual (Resuscitator)). 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Custom”

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

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

Custom Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Custom”