510(k) Report

FDA applicant

Neomedix Corp.

San Juan Capistrano, CA4 decisions2003–20061 recall

FDA records 4 decisions for Neomedix Corp. (San Juan Capistrano, CA) from 2003 to 2006: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). Its devices cite 13 predicates, 1 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Neomedix Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neomedix Corp. 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 — Neomedix Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neomedix Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K040239Supraflow ConsoleNeomedix Corp. · 20041cites it
  • K040584NMX-1000Neomedix Corp. · 20041cites it
  • K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 20031cites it

What has FDA decided for it lately?

  • K061258Trabectome High Frequency Generator/LPNeomedix Corp. · 2006
  • K040584NMX-1000Neomedix Corp. · 2004
  • K040239Supraflow ConsoleNeomedix Corp. · 20041 recall
  • K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 2003

All 4 as Neomedix Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K040239NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspiratorMay 28, 2007