510(k) Report

FDA applicant

Mark-Clark

Topka, KS2 decisions1994–19960 recalls

FDA records 2 decisions for Mark-Clark (Topka, KS) from 1994 to 1996: 2 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and LYU (Accessory, Surgical Apparel). 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 Mark-Clark’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mark-Clark since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mark-Clark 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?

  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • LYUAccessory, Surgical Apparel1decision

What has FDA decided for it lately?

  • K961884Cath CaddieMark-Clark · 1996
  • K940723Body BootMark-Clark · 1994

All 2 as Mark-Clark →

Other applicant names beginning “Mark-Clark”

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

Mark One Healthcare Products 5Mark Abramson, D.D.S., Inc. 2Mark H. Friedman 2Mark Solutions, Inc. 1Mark Sullivan, M.D., P.C. 1