510(k) Report

FDA applicant

Simpex, Inc.

Jenkintown, PA5 decisions1991–19920 recalls

FDA records 5 decisions for Simpex, Inc. (Jenkintown, PA) from 1991 to 1992: 5 510(k) clearances. Most are in product codes HTY (Pin, Fixation, Smooth) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 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 Simpex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Simpex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Simpex, 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?

  • HTYPin, Fixation, Smooth2decisions
  • GDYGauze/Sponge, Internal, X-Ray Detectable1decision
  • LYYLatex Patient Examination Glove1decision
  • FLKThermometer, Clinical Mercury1decision

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.

  • K911505Fixation WireSimpex, Inc. · 19911cites it

What has FDA decided for it lately?

  • K920174Easy Touch Latex Eam GlovesSimpex, Inc. · 1992
  • K913793Simpex Inc. Oral and Rectal ThermometersSimpex, Inc. · 1991
  • K913794Simpex Inc. Surgical DressingSimpex, Inc. · 1991
  • K911505Fixation WireSimpex, Inc. · 1991
  • K911452Fixation PinSimpex, Inc. · 1991

All 5 as Simpex, Inc. →