510(k) Report

FDA applicant

Sure-Way Systems, Inc.

Wilmington, CA1 decision1999–19990 recalls

FDA records 1 decision for Sure-Way Systems, Inc. (Wilmington, CA) in 1999: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Sure-Way Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sure-Way Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sure-Way Systems, Inc. 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?

  • FMINeedle, Hypodermic, Single Lumen1decision

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.

  • K992626Sure-Way Reusable Sharps ContainerSure-Way Systems, Inc. · 19991cites it

What has FDA decided for it lately?

  • K992626Sure-Way Reusable Sharps ContainerSure-Way Systems, Inc. · 1999

The one decision as Sure-Way Systems, Inc. →

Other applicant names beginning “Sure-Way”

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

Sure, Inc. 1Sure-Tech Diagnostic Associates, Inc. 1