510(k) Report

FDA applicant

Sti Medical

Cedar Grove, NJ1 decision2000–20000 recalls

FDA records 1 decision for Sti Medical (Cedar Grove, NJ) in 2000: 1 510(k) clearance. All are in product code BZH (Meter, Peak Flow, Spirometry). 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 Sti Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sti Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sti Medical 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?

  • BZHMeter, Peak Flow, Spirometry1decision

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.

  • K980951OneflowSti Medical · 20001cites it

What has FDA decided for it lately?

The one decision as Sti Medical →