510(k) Report

FDA applicant

Healthcare Management Systems

Sparks, NV1 decision1987–19870 recalls

FDA records 1 decision for Healthcare Management Systems (Sparks, NV) in 1987: 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 Healthcare Management Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthcare Management Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Healthcare Management Systems 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

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.

  • K864218ProconHealthcare Management Systems · 19871cites it

What has FDA decided for it lately?

  • K864218ProconHealthcare Management Systems · 1987

The one decision as Healthcare Management Systems →