510(k) Report

FDA applicant

Autovage

South Park, PA7 decisions1982–19920 recalls

FDA records 7 decisions for Autovage (South Park, PA) from 1982 to 1992: 7 510(k) clearances. Most are in product codes KDH (Catheter (Gastric, Colonic, Etc.), Irrigation…) and KNT (Tubes, Gastrointestinal (And Accessories)). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Autovage since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Autovage 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?

  • KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration4decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • BTRTube, Tracheal (W/Wo Connector)1decision
  • EYFProtector, Wound, Plastic1decision

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.

  • K840943Endo-JectAutovage · 19841cites it

What has FDA decided for it lately?

All 7 as Autovage →