510(k) Report

FDA applicant

Global Instrumentation, LLC

Manlius, NY5 decisions2005–20260 recalls

FDA records 5 decisions for Global Instrumentation, LLC (Manlius, NY) from 2005 to 2026: 5 510(k) clearances. Most are in product codes MLO (Electrocardiograph, Ambulatory, With Analysis…) and DSI (Detector And Alarm, Arrhythmia). Since 2016 its 510(k)s took a median of 239 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 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, cardiovascular panel, where it files most

How often FDA has decided Global Instrumentation, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12017: 12020: 12026 (partial year): 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Global Instrumentation, LLC 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?

  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm1decision
  • DSIDetector And Alarm, Arrhythmia1decision
  • DSHRecorder, Magnetic Tape, Medical1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 239 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 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.

  • K051730Matrix Holter System, Model M12Global Instrumentation, LLC · 20051cites it
  • K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC · 20161cites it

What has FDA decided for it lately?

  • K252840M12 Telemetry SystemGlobal Instrumentation, LLC · 2026
  • K202456M5 RecorderGlobal Instrumentation, LLC · 2020
  • K162463Matrix Data Management SystemGlobal Instrumentation, LLC · 2017
  • K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC · 2016
  • K051730Matrix Holter System, Model M12Global Instrumentation, LLC · 2005

All 5 as Global Instrumentation, LLC →