510(k) Report

FDA applicant

Pro. Duct Health, Inc.

Menlo Park, CA2 decisions2000–20000 recalls

FDA records 2 decisions for Pro. Duct Health, Inc. (Menlo Park, CA) in 2000: 2 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FMI (Needle, Hypodermic, Single Lumen). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Pro. Duct Health, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pro. Duct Health, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • KNWInstrument, Biopsy1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

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.

  • K000135Pro.Duct Catheter, Model CTH03Pro. Duct Health, Inc. · 20001cites it

What has FDA decided for it lately?

  • K001098Pro.Duct Health Micro-Stylet, Model STY01Pro. Duct Health, Inc. · 2000
  • K000135Pro.Duct Catheter, Model CTH03Pro. Duct Health, Inc. · 2000

All 2 as Pro. Duct Health, Inc. →