510(k) Report

FDA applicant

Medical Device Inspection Co., Inc.

Great Neck, NY30 decisions1990–19951 recall

FDA records 30 decisions for Medical Device Inspection Co., Inc. (Great Neck, NY) from 1990 to 1995: 30 510(k) clearances. Most are in product codes FSM (Tray, Surgical, Instrument) and INQ (Table, Powered). 1 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 Device Inspection Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Device Inspection Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Device Inspection Co., 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?

  • FSMTray, Surgical, Instrument4decisions
  • INQTable, Powered4decisions
  • MCYWound Dressing Kit2decisions
  • LYYLatex Patient Examination Glove2decisions
  • EMACement, Dental2decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions

Also: HCC (1), HET (1), KNA (1), HFW (1), LRP (1), INM (1).

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.

  • K945826J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software ApplicationsMedical Device Inspection Co., Inc. · 19952cite it
  • K931594Thera-Turn CM-1000 Mattress Overlay SystemMedical Device Inspection Co., Inc. · 19931cites it

What has FDA decided for it lately?

  • K945826J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software ApplicationsMedical Device Inspection Co., Inc. · 1995
  • K932072Jarit Surgical InstrumentsMedical Device Inspection Co., Inc. · 1994
  • K931594Thera-Turn CM-1000 Mattress Overlay SystemMedical Device Inspection Co., Inc. · 1993
  • K933580Power Work TableMedical Device Inspection Co., Inc. · 1993
  • K933581Powermatic Treatment TableMedical Device Inspection Co., Inc. · 1993
  • K933578Powermatic Mat PlatformMedical Device Inspection Co., Inc. · 1993
  • K933577Powermatic Examination TableMedical Device Inspection Co., Inc. · 1993
  • K922045Shower ChairsMedical Device Inspection Co., Inc. · 1992

All 30 as Medical Device Inspection Co., Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K914174Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical…Nov 21, 2006