510(k) Report

FDA applicant

Hidalgo Limited

Swavesey Cambridge, GB2 decisions2006–20120 recalls

FDA records 2 decisions for Hidalgo Limited (Swavesey Cambridge, GB) from 2006 to 2012: 2 510(k) clearances. All are in product code MHX (Monitor, Physiological, Patient (With…). Its devices cite 13 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Hidalgo Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hidalgo Limited 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?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K061993Equivital, Model EQ-01Hidalgo Limited · 20063cite it
  • K113054EquivitalHidalgo Limited · 20121cites it

What has FDA decided for it lately?

  • K113054EquivitalHidalgo Limited · 2012
  • K061993Equivital, Model EQ-01Hidalgo Limited · 2006

All 2 as Hidalgo Limited →