510(k) Report

FDA applicant

Lerman & Son

Beverly Hills, CA1 decision2001–20010 recalls

FDA records 1 decision for Lerman & Son (Beverly Hills, CA) in 2001: 1 510(k) clearance. All are in product code MVA (Orthosis, Cranial). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, neurology panel, where it files most

How often FDA has decided Lerman & Son’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lerman & Son since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lerman & Son 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?

  • MVAOrthosis, Cranial1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K012830Lerman & Son Cranial Orthosis HelmetLerman & Son · 2001

The one decision as Lerman & Son →