510(k) Report

FDA applicant

Moti Enterprises, Inc.

Mchenry, IL3 decisions1980–19840 recalls

FDA records 3 decisions for Moti Enterprises, Inc. (Mchenry, IL) from 1980 to 1984: 3 510(k) clearances. Most are in product codes KPY (Shield, Protective, Personnel) and IZH (System, X-Ray, Mammographic). 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, radiology panel, where it files most

How often FDA has decided Moti Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Moti Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Moti Enterprises, Inc. 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?

  • KPYShield, Protective, Personnel2decisions
  • IZHSystem, X-Ray, Mammographic1decision

What has FDA decided for it lately?

  • K843437Mei Mammography Sys MX-2049Moti Enterprises, Inc. · 1984
  • K810095Moti ApronMoti Enterprises, Inc. · 1981
  • K802377Moti Protective X-Ray MaskMoti Enterprises, Inc. · 1980

All 3 as Moti Enterprises, Inc. →