510(k) Report

FDA applicant

Mbo Laboratories, Inc.

North Chelmsford, MA3 decisions1991–19920 recalls

FDA records 3 decisions for Mbo Laboratories, Inc. (North Chelmsford, MA) from 1991 to 1992: 3 510(k) clearances. Most are in product codes GIM (Tubes, Vacuum Sample, With Anticoagulant) and FOZ (Catheter, Intravascular, Therapeutic…). 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, clinical chemistry panel, where it files most

How often FDA has decided Mbo Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mbo Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mbo Laboratories, 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?

  • GIMTubes, Vacuum Sample, With Anticoagulant2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K912563Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 19913cite it

What has FDA decided for it lately?

  • K922468Angel Wing Sets -- ModifiedMbo Laboratories, Inc. · 1992
  • K920184Angel Wing Safety Blood Collection with Tube Hold.Mbo Laboratories, Inc. · 1992
  • K912563Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991

All 3 as Mbo Laboratories, Inc. →