510(k) Report

FDA applicant

Pertrach

Bridgeport, WV2 decisions1989–19920 recalls

FDA records 2 decisions for Pertrach (Bridgeport, WV) from 1989 to 1992: 2 510(k) clearances. All are in product code BTO (Tube, Tracheostomy (W/Wo Connector)). 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 Pertrach’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pertrach since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pertrach 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?

  • BTOTube, Tracheostomy (W/Wo Connector)2decisions

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.

  • K914743Emergency Percutaneous Cricothyroidotomy Kit,ModifPertrach · 19922cite it

What has FDA decided for it lately?

  • K914743Emergency Percutaneous Cricothyroidotomy Kit,ModifPertrach · 1992
  • K885139Modified Adult Cricothyroidotomy KitPertrach · 1989

All 2 as Pertrach →