510(k) Report

FDA applicant

Chalgren Enterprises, Inc.

Gilroy, CA21 decisions1989–19991 recall

FDA records 21 decisions for Chalgren Enterprises, Inc. (Gilroy, CA) from 1989 to 1999: 21 510(k) clearances. Most are in product codes IKT (Electrode, Needle, Diagnostic Electromyograph) and GXY (Electrode, Cutaneous). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Chalgren Enterprises, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Chalgren 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?

  • IKTElectrode, Needle, Diagnostic Electromyograph9decisions
  • GXYElectrode, Cutaneous8decisions
  • JXEDevice, Nerve Conduction Velocity Measurement2decisions
  • HLTPreamplifier, Ac-Powered, Ophthalmic1decision
  • GXZElectrode, Needle1decision

Who builds on its devices?

Later devices cite its devices 16 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.

  • K912282Disposable Monopolar Needle Electrode, Var ModelsChalgren Enterprises, Inc. · 19923cite it
  • K953887RE-Usable Concentric NeedleChalgren Enterprises, Inc. · 19952cite it
  • K955335Disposable Hypodermic Monopolar Needle Recording ElectrodeChalgren Enterprises, Inc. · 19962cite it
  • K960591RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPChalgren Enterprises, Inc. · 19962cite it
  • K924521Disposable Concentric Needle ElectrodeChalgren Enterprises, Inc. · 19932cite it
  • K953886RE-Usable Monopolar NeedleChalgren Enterprises, Inc. · 19952cite it

What has FDA decided for it lately?

  • K982950Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550Chalgren Enterprises, Inc. · 1999
  • K960591RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPChalgren Enterprises, Inc. · 1996
  • K955335Disposable Hypodermic Monopolar Needle Recording ElectrodeChalgren Enterprises, Inc. · 1996
  • K953354Emg Disc Recording ElectrodeChalgren Enterprises, Inc. · 1996
  • K953356Emg Recording Ring ElectrodeChalgren Enterprises, Inc. · 1996
  • K953361Emg Disc Recording ElectrodeChalgren Enterprises, Inc. · 1996
  • K952908Emg Disc Recording Electrode with PinChalgren Enterprises, Inc. · 1995
  • K952690Emg Disc Recording Electrode with PinChalgren Enterprises, Inc. · 1995

All 21 as Chalgren Enterprises, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K912283Disposable Detachable Monopolar Needle Electrode for electromyograph model number…Apr 12, 2007