510(k) Report

FDA applicant

International Regulatory Consultants

Gaithersburg, MD5 decisions1994–19980 recalls

FDA records 5 decisions for International Regulatory Consultants (Gaithersburg, MD) from 1994 to 1998: 5 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FAD (Stent, Ureteral). Its devices cite 1 predicate, 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 International Regulatory Consultants’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Regulatory Consultants since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — International Regulatory Consultants 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?

  • FMFSyringe, Piston1decision
  • FADStent, Ureteral1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • LMDSystem, Digital Image Communications, Radiological1decision
  • FLLContinuous Measurement Thermometer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K971347MedisurfInternational Regulatory Consultants · 19975cite it
  • K981591Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentInternational Regulatory Consultants · 19984cite it
  • K962614Shifa Sterile Disposable SyringesInternational Regulatory Consultants · 19961cites it

What has FDA decided for it lately?

  • K981591Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentInternational Regulatory Consultants · 1998
  • K971347MedisurfInternational Regulatory Consultants · 1997
  • K962614Shifa Sterile Disposable SyringesInternational Regulatory Consultants · 1996
  • K950012Dispomedic Disposable Syringes and NeedlesInternational Regulatory Consultants · 1995
  • K935280Memotherm 10 Baby ThermometerInternational Regulatory Consultants · 1994

All 5 as International Regulatory Consultants →