510(k) Report

FDA applicant

Jinotti Ent Inc. Medical

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Jinotti Ent Inc. Medical (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code BSY (Catheters, Suction, Tracheobronchial). 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 Jinotti Ent Inc. Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jinotti Ent Inc. Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jinotti Ent Inc. 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?

  • BSYCatheters, Suction, Tracheobronchial1decision

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.

  • K833375Dual Purpose CatheterJinotti Ent Inc. Medical · 19841cites it

What has FDA decided for it lately?

  • K833375Dual Purpose CatheterJinotti Ent Inc. Medical · 1984

The one decision as Jinotti Ent Inc. Medical →