510(k) Report

FDA applicant

Polyclinic Medical Center

Mchenry, IL2 decisions1983–19931 recall

FDA records 2 decisions for Polyclinic Medical Center (Mchenry, IL) from 1983 to 1993: 2 510(k) clearances. Most are in product codes JAY (Support, Breathing Tube) and KKY (Material, Polytetrafluoroethylene Vitreous…). 1 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 Polyclinic Medical Center’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polyclinic Medical Center since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Polyclinic Medical Center 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?

  • JAYSupport, Breathing Tube1decision
  • KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K924935Hard Tissue Replace (HTR (R))-Patient-Match ImplantPolyclinic Medical Center · 19932cite it

What has FDA decided for it lately?

  • K924935Hard Tissue Replace (HTR (R))-Patient-Match ImplantPolyclinic Medical Center · 19931 recall
  • K833332Schultz EndholdPolyclinic Medical Center · 1983

All 2 as Polyclinic Medical Center →

What has been recalled?

1 recall linked to its devices; the latest:

  • K924935Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom…Jun 13, 2016Class II