FDA applicant

Custom Cardio Components

Mchenry, IL2 decisions1980–19800 recalls

FDA records 2 decisions for Custom Cardio Components (Mchenry, IL) in 1980: 2 510(k) clearances. All are in product code DSA (Cable, Transducer And Electrode, Patient…). 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, cardiovascular panel, where it files most

How often FDA has decided Custom Cardio Components’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Custom Cardio Components since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Custom Cardio Components 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, Inc. 3 Custom Medical Devices Intl., Inc. 3 Custom Medical Plastics, Inc. 2 Custom Hospitals Products 1

Custom Cardio Components

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Custom”