510(k) Report

FDA applicant

Dow Corning Corp. Healthcare Industries Materials

Mchenry, IL31 decisions1976–19850 recalls

FDA records 31 decisions for Dow Corning Corp. Healthcare Industries Materials (Mchenry, IL) from 1976 to 1985: 31 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and KWH (Prosthesis, Toe, Constrained, Polymer). 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, orthopedic panel, where it files most

How often FDA has decided Dow Corning Corp. Healthcare Industries Materials’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dow Corning Corp. Healthcare Industries Materials since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dow Corning Corp. Healthcare Industries Materials 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?

  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • KWHProsthesis, Toe, Constrained, Polymer2decisions
  • GBOCatheter, Nephrostomy, General & Plastic Surgery2decisions
  • GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered2decisions
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal2decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision

Also: LTC (1), FOZ (1), EWL (1), KXE (1), KNY (1), HQX (1).

Who builds on its devices?

Later devices cite its devices 4 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.

  • K801094Silastic Hammertoe Implant (Swanson-WellDow Corning Corp. Healthcare Industries Materials · 19801cites it
  • K781756Silastic H.P. Trapexial ImplantDow Corning Corp. Healthcare Industries Materials · 19781cites it
  • K781870Implant, H.P. CondylarDow Corning Corp. Healthcare Industries Materials · 19791cites it
  • K780132Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 19781cites it

What has FDA decided for it lately?

  • K853186Silastic Inflatable Bone Plug H.P.Dow Corning Corp. Healthcare Industries Materials · 1985
  • K844637Whiteside Acrylic Cement Spacer SleeveDow Corning Corp. Healthcare Industries Materials · 1985
  • K850255Dow Corning Wright Titanium Wrist Joint GrommetDow Corning Corp. Healthcare Industries Materials · 1985
  • K843995TF-II Hip ProsthesisDow Corning Corp. Healthcare Industries Materials · 1985
  • K842559Whiteside Ortholoc Total Hip FemoralDow Corning Corp. Healthcare Industries Materials · 1984
  • K840357Ssa Hip ProsthesisDow Corning Corp. Healthcare Industries Materials · 1984
  • K831479Metal-Backed Acetabular CupDow Corning Corp. Healthcare Industries Materials · 1983
  • K812864Silastic Voice ProsthesisDow Corning Corp. Healthcare Industries Materials · 1981

All 31 as Dow Corning Corp. Healthcare Industries Materials →