510(k) Report

FDA applicant

A.Stein - Regulatory Affairs Consulting

Ginot Shomron 44853, IL5 decisions1997–19990 recalls

FDA records 5 decisions for A.Stein - Regulatory Affairs Consulting (Ginot Shomron 44853, IL) from 1997 to 1999: 5 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and KLZ (Tube, Shunt, Endolymphatic With Valve). 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, cardiovascular panel, where it files most

How often FDA has decided A.Stein - Regulatory Affairs Consulting’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for A.Stein - Regulatory Affairs Consulting since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — A.Stein - Regulatory Affairs Consulting 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?

  • JOWSleeve, Limb, Compressible1decision
  • KLZTube, Shunt, Endolymphatic With Valve1decision
  • FWFCamera, Television, Endoscopic, Without Audio1decision
  • LKXDevice, Thermal, Hemorrhoids1decision
  • LLZSystem, Image Processing, Radiological1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K972383Easy-Jet DeviceA.Stein - Regulatory Affairs Consulting · 19991cites it

What has FDA decided for it lately?

  • K972383Easy-Jet DeviceA.Stein - Regulatory Affairs Consulting · 1999
  • K973592Walkcare P200 SystemA.Stein - Regulatory Affairs Consulting · 1999
  • K982754EC-1000-7 Digital Endoscopy Video Camera, Models EC 1000-7P (Pal) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs Consulting · 1999
  • K973590Hemorrelief DeviceA.Stein - Regulatory Affairs Consulting · 1998
  • K973148MACOMA.Stein - Regulatory Affairs Consulting · 1997

All 5 as A.Stein - Regulatory Affairs Consulting →