510(k) Report

FDA applicant

Medical Specialty Innovations, Inc. (Msi)

Great Neck, NY2 decisions1997–19980 recalls

FDA records 2 decisions for Medical Specialty Innovations, Inc. (Msi) (Great Neck, NY) from 1997 to 1998: 2 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Medical Specialty Innovations, Inc. (Msi)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Specialty Innovations, Inc. (Msi) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Specialty Innovations, Inc. (Msi) 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?

  • LHISet, I.V. Fluid Transfer1decision
  • KKXDrape, Surgical, Antimicrobial1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K972117Msi Bottleflow, Transflow, VialflowMedical Specialty Innovations, Inc. (Msi) · 19971cites it

What has FDA decided for it lately?

  • K974672Msi Surgical DrapesMedical Specialty Innovations, Inc. (Msi) · 1998
  • K972117Msi Bottleflow, Transflow, VialflowMedical Specialty Innovations, Inc. (Msi) · 1997

All 2 as Medical Specialty Innovations, Inc. (Msi) →