510(k) Report

FDA applicant

Biomedical Horizons, Inc.

Jackson, MI2 decisions1992–19980 recalls

FDA records 2 decisions for Biomedical Horizons, Inc. (Jackson, MI) from 1992 to 1998: 2 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and KNN (Components, Wheelchair). 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 Biomedical Horizons, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomedical Horizons, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biomedical Horizons, Inc.’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?

  • JOWSleeve, Limb, Compressible1decision
  • KNNComponents, Wheelchair1decision

What has FDA decided for it lately?

  • K971892Biomedical Horizons Inc. Compression Pump, Model 651Biomedical Horizons, Inc. · 1998
  • K921369Biomedical Horizons Model 1001Biomedical Horizons, Inc. · 1992

All 2 as Biomedical Horizons, Inc. →