510(k) Report

FDA applicant

Bio Medi Com

Indianpolis, IN3 decisions2001–20020 recalls

FDA records 3 decisions for Bio Medi Com (Indianpolis, IN) from 2001 to 2002: 3 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 8 predicates, 3 of them its own earlier devices. 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, radiology panel, where it files most

How often FDA has decided Bio Medi Com’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio Medi Com since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K012084Sonoreal 3DBio Medi Com · 20012cite it
  • K023473Sonoreal 3DBio Medi Com · 20021cites it
  • K020068Sonoreal 3D SystemBio Medi Com · 20021cites it

What has FDA decided for it lately?

  • K023473Sonoreal 3DBio Medi Com · 2002
  • K020068Sonoreal 3D SystemBio Medi Com · 2002
  • K012084Sonoreal 3DBio Medi Com · 2001

All 3 as Bio Medi Com →