510(k) Report

FDA applicant

Diagnostic Group, LLC

Minnesota, MN1 decision2010–20100 recalls

FDA records 1 decision for Diagnostic Group, LLC (Minnesota, MN) in 2010: 1 510(k) clearance. All are in product code EWO (Audiometer). 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, ear, nose and throat panel, where it files most

How often FDA has decided Diagnostic Group, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Diagnostic Group, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EWOAudiometer1decision

What has FDA decided for it lately?

  • K092244MA61, MA62, MA63 Family of Portable AudiometersDiagnostic Group, LLC · 2010

The one decision as Diagnostic Group, LLC →

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Systems Laboratories, Inc. 94Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic Reagents, Inc. 66Diagnostic Chemicals, Ltd. 66Diagnostic Hybrids, Inc. 37Diagnostic Technology, Inc. 28Diagnostic Solutions, Inc. 26Diagnostic Ultrasound Corp. 16Diagnostic Systems 14Diagnostic Reagent Tech. 10Diagnostic Specialties 8