510(k) Report

FDA applicant

Leon'S Fecal Sanitary Tub Mfg.

Walker, MI1 decision1982–19820 recalls

FDA records 1 decision for Leon'S Fecal Sanitary Tub Mfg. (Walker, MI) in 1982: 1 510(k) clearance. All are in product code 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 Leon'S Fecal Sanitary Tub Mfg.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leon'S Fecal Sanitary Tub Mfg. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leon'S Fecal Sanitary Tub Mfg. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Leon'S Fecal Sanitary Tub Mfg.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)1decision

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.

  • K813526Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 19822cite it

What has FDA decided for it lately?

  • K813526Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982

The one decision as Leon'S Fecal Sanitary Tub Mfg. →

Other applicant names beginning “Leon'S”

FDA records each applicant name separately; these may or may not be the same firm.

Leon H. Lang Co. 1