510(k) Report

FDA applicant

The Langer Group

Mchenry, IL2 decisions1982–19820 recalls

FDA records 2 decisions for The Langer Group (Mchenry, IL) in 1982: 2 510(k) clearances. Most are in product codes ITN (Splint, Denis Brown) and KHX (Platform, Force-Measuring). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for The Langer Group since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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