510(k) Report

FDA applicant

W.E. Leder Enterprises, Inc.

Mchenry, IL6 decisions1983–19830 recalls

FDA records 6 decisions for W.E. Leder Enterprises, Inc. (Mchenry, IL) in 1983: 6 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CBK (Ventilator, Continuous, Facility Use). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for W.E. Leder Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — W.E. Leder 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?

  • BSZGas-Machine, Anesthesia3decisions
  • CBKVentilator, Continuous, Facility Use1decision
  • CCWLaryngoscope, Rigid1decision
  • DPSElectrocardiograph1decision

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.

  • K831981LaryngescopeW.E. Leder Enterprises, Inc. · 19831cites it

What has FDA decided for it lately?

  • K831877ARF 850 EW.E. Leder Enterprises, Inc. · 1983
  • K831981LaryngescopeW.E. Leder Enterprises, Inc. · 1983
  • K831878Cardio-Scope Mini MonitorW.E. Leder Enterprises, Inc. · 1983
  • K830159Anesthesia Apparatus PH-35W.E. Leder Enterprises, Inc. · 1983
  • K830161Anesthesia Apatatus #D-25W.E. Leder Enterprises, Inc. · 1983
  • K830160Anesthesia Apparatus #FO 20SW.E. Leder Enterprises, Inc. · 1983

All 6 as W.E. Leder Enterprises, Inc. →