510(k) Report

FDA applicant

Mark H. Friedman

Scarsdale, NY2 decisions1996–20040 recalls

FDA records 2 decisions for Mark H. Friedman (Scarsdale, NY) from 1996 to 2004: 2 510(k) clearances. All are in product code ILO (Pack, Hot Or Cold, Water Circulating). Its devices cite 8 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, physical medicine panel, where it files most

How often FDA has decided Mark H. Friedman’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mark H. Friedman since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mark H. Friedman 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?

  • ILOPack, Hot Or Cold, Water Circulating2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K040317Ivc SystemMark H. Friedman · 2004
  • K955529Crytron SystemMark H. Friedman · 1996

All 2 as Mark H. Friedman →

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-Clark 2Mark Solutions, Inc. 1Mark Sullivan, M.D., P.C. 1