510(k) Report

FDA applicant

3pm Co., Inc.

Washington, DC1 decision1999–19990 recalls

FDA records 1 decision for 3pm Co., Inc. (Washington, DC) in 1999: 1 De Novo grant. All are in product code MYE (System, Electrogastrography (Egg)). 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 3pm Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3pm Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3pm Co., 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?

  • MYESystem, Electrogastrography (Egg)1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • DEN990005The 3PM Egg Machine3pm Co., Inc. · 19993cite it

What has FDA decided for it lately?

  • DEN990005The 3PM Egg Machine3pm Co., Inc. · 1999

The one decision as 3pm Co., Inc. →