FDA applicant
The Langer Group
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
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.
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.
See the 510(k) Report