510(k) Report

FDA applicant

Biomedical Systems Corp.

St. Louis, MO3 decisions1988–20100 recalls

FDA records 3 decisions for Biomedical Systems Corp. (St. Louis, MO) from 1988 to 2010: 3 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biomedical Systems, Inc.”.

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 Biomedical Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biomedical Systems Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DSIDetector And Alarm, Arrhythmia2decisions
  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K884152Century Color TraceBiomedical Systems, Inc. · 19883cite it
  • K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 20103cite it
  • K024323Century Series Holter Scanner System, Models C3000, C2000 and C1000Biomedical Systems Corp. · 20031cites it

What has FDA decided for it lately?

  • K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
  • K024323Century Series Holter Scanner System, Models C3000, C2000 and C1000Biomedical Systems Corp. · 2003
  • K884152Century Color TraceBiomedical Systems, Inc. · 1988

All 2 as Biomedical Systems Corp. →The one decision as Biomedical Systems, Inc. →