510(k) Report

FDA applicant

Competent Design

Mchenry, IL1 decision1980–19800 recalls

FDA records 1 decision for Competent Design (Mchenry, IL) in 1980: 1 510(k) clearance. All are in product code FMR (Device, Transfer, Patient, Manual). 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, general hospital panel, where it files most

How often FDA has decided Competent Design’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Competent Design since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Competent Design’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?

  • FMRDevice, Transfer, Patient, Manual1decision

What has FDA decided for it lately?

  • K800373TenderliftCompetent Design · 1980

The one decision as Competent Design →