510(k) Report

FDA applicant

Handren Assoc.

Leesburg, FL1 decision1998–19980 recalls

FDA records 1 decision for Handren Assoc. (Leesburg, FL) in 1998: 1 510(k) clearance. All are in product code MMK (Container, Sharps). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Handren Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Handren Assoc. 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?

  • MMKContainer, Sharps1decision

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.

  • K983367QlicksmartHandren Assoc. · 19981cites it

What has FDA decided for it lately?

  • K983367QlicksmartHandren Assoc. · 1998

The one decision as Handren Assoc. →