510(k) Report

FDA applicant

Panatrex, Inc.

Placentia, CA2 decisions1998–20040 recalls

FDA records 2 decisions for Panatrex, Inc. (Placentia, CA) from 1998 to 2004: 2 510(k) clearances. Most are in product codes HIB (Speculum, Vaginal, Nonmetal) and SCL (Allergen And Vaccine Delivery Needles). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Panatrex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Panatrex, 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?

  • HIBSpeculum, Vaginal, Nonmetal1decision
  • SCLAllergen And Vaccine Delivery Needles1decision

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.

  • K042950Vag O Speculum, Models VS1, VM1, VL1Panatrex, Inc. · 20041cites it

What has FDA decided for it lately?

  • K042950Vag O Speculum, Models VS1, VM1, VL1Panatrex, Inc. · 2004
  • K982578Quanti-Test SystemPanatrex, Inc. · 1998

All 2 as Panatrex, Inc. →