510(k) Report

FDA applicant

Ametek, Inc.

Pittsburgh, PA3 decisions1995–20040 recalls

FDA records 3 decisions for Ametek, Inc. (Pittsburgh, PA) from 1995 to 2004: 3 510(k) clearances. Most are in product codes LBB (Dynamometer, Ac-Powered) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). No recall is linked to its devices.

FDA’s records also spell it “Ametek”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Ametek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ametek, 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?

  • LBBDynamometer, Ac-Powered1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K042889Dynamometer - Model Fce and Model MSCAmetek · 20042cite it

What has FDA decided for it lately?

  • K042889Dynamometer - Model Fce and Model MSCAmetek · 2004
  • K943824Gaseous Oxygen Analyzer (Model S-3A) ModificationAmetek, Inc. · 1996
  • K942113Carbon Dioxide Analyzer (Model CD-3A)Ametek, Inc. · 1995

All 2 as Ametek, Inc. →The one decision as Ametek →

Other applicant names beginning “Ametek”

FDA records each applicant name separately; these may or may not be the same firm.

Ametek/Thermox Instruments Division 2