510(k) Report

FDA applicant

Med-Safe Systems, Inc.

Oceanside, CA8 decisions1994–19940 recalls

FDA records 8 decisions for Med-Safe Systems, Inc. (Oceanside, CA) in 1994: 8 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and 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 Med-Safe Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-Safe Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Med-Safe 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 Lumen7decisions
  • MMKContainer, Sharps1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K943134B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 19942cite it
  • K943139B-D Guardian One Piece Sharps CollectorsMed-Safe Systems, Inc. · 19942cite it

What has FDA decided for it lately?

  • K943138Vacutainer Brand Needle Disposal ContainerMed-Safe Systems, Inc. · 1994
  • K943139B-D Guardian One Piece Sharps CollectorsMed-Safe Systems, Inc. · 1994
  • K943136B-D Guardian Point-of-Use Vertical Entry Sharps CollectorsMed-Safe Systems, Inc. · 1994
  • K943135Med-Safe Insulin Sharps ContainerMed-Safe Systems, Inc. · 1994
  • K943140B-D Guradian Chemotherapy Sharps CollectorsMed-Safe Systems, Inc. · 1994
  • K943134B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
  • K943137B-D/Bfi Mail Disposal ServiceMed-Safe Systems, Inc. · 1994
  • K943141B-D Guardian Point of Use Horizontal and Side Entry Sharps CollectorsMed-Safe Systems, Inc. · 1994

All 8 as Med-Safe Systems, Inc. →