510(k) Report

FDA applicant

Gulmay Medical, Ltd.

Shepperton, Middlesex, GB1 decision1996–19962 recalls

FDA records 1 decision for Gulmay Medical, Ltd. (Shepperton, Middlesex, GB) in 1996: 1 510(k) clearance. All are in product code JAD (System, Therapeutic, X-Ray). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Gulmay Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gulmay Medical, Ltd. since 2007.

Recalls per year

2in 2021

2021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gulmay Medical, Ltd. 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?

  • JADSystem, Therapeutic, X-Ray1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K962613Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 19962cite it

What has FDA decided for it lately?

  • K962613Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 19962 recalls

The one decision as Gulmay Medical, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K962613Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy…Aug 27, 2021Class II
  • K172080Concerto User Interface Software provided with the following systems: (1) Xstrahl 100…Apr 26, 2021Class II