510(k) Report

FDA applicant

Mediwatch, Ltd.

Warwickshire, GB2 decisions2003–20050 recalls

FDA records 2 decisions for Mediwatch, Ltd. (Warwickshire, GB) from 2003 to 2005: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mediwatch Plc”.

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 Mediwatch, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mediwatch, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mediwatch, 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

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 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.

  • K053325Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System…Mediwatch, Ltd. · 20051cites it
  • K033906Portascan Bladder Scanner, Model PA00146Mediwatch Plc · 20031cites it

What has FDA decided for it lately?

  • K053325Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System…Mediwatch, Ltd. · 2005
  • K033906Portascan Bladder Scanner, Model PA00146Mediwatch Plc · 2003

The one decision as Mediwatch, Ltd. →The one decision as Mediwatch Plc →