510(k) Report

FDA applicant

Mark Solutions, Inc.

Maywood, NJ1 decision1995–19950 recalls

FDA records 1 decision for Mark Solutions, Inc. (Maywood, NJ) in 1995: 1 510(k) clearance. All are in product code LGM (Chamber, Patient Isolation). 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 Mark Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mark Solutions, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mark Solutions, 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?

  • LGMChamber, Patient Isolation1decision

What has FDA decided for it lately?

  • K944133MTB 1043 Treatment BoothMark Solutions, Inc. · 1995

The one decision as Mark Solutions, Inc. →

Other applicant names beginning “Mark”

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

Mark One Healthcare Products 5Mark Abramson, D.D.S., Inc. 2Mark H. Friedman 2Mark-Clark 2Mark Sullivan, M.D., P.C. 1