510(k) Report

FDA applicant

Frontier Products

Mchenry, IL4 decisions1980–19830 recalls

FDA records 4 decisions for Frontier Products (Mchenry, IL) from 1980 to 1983: 4 510(k) clearances. Most are in product codes DXQ (Blood Pressure Cuff) and DXP (Transducer, Vessel Occlusion). 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 Frontier Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Frontier Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DXQBlood Pressure Cuff2decisions
  • DXPTransducer, Vessel Occlusion1decision
  • HTHProtractor1decision

What has FDA decided for it lately?

  • K831001Unicuff-Blood Pressure CuffFrontier Products · 1983
  • K822305Ortho-LevelFrontier Products · 1982
  • K812639UnicuffFrontier Products · 1981
  • K801099Unicuf, Blood Pressure CuffFrontier Products · 1980

All 4 as Frontier Products →

Other applicant names beginning “Frontier”

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

Frontier Medical Devices, Inc. 5Frontier Novelty, Inc. 4Frontier Devices, Inc. 1