510(k) Report

FDA applicant

Key Instruments

Trevose, PA1 decision1989–19890 recalls

FDA records 1 decision for Key Instruments (Trevose, PA) in 1989: 1 510(k) clearance. All are in product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Key Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Key Instruments 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?

  • CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1decision

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.

  • K884973FR6000 FlowmeterKey Instruments · 19891cites it

What has FDA decided for it lately?

  • K884973FR6000 FlowmeterKey Instruments · 1989

The one decision as Key Instruments →