# Global Instrumentation, LLC

- Location (FDA's records): Manlius, NY
- FDA decisions: 5 (2005–2026): 5 510(k) clearances
- Product codes: MLO (1), DSI (1), DSH (1), DXN (1), MHX (1)
- 510(k) review time since 2016: median 239 days, against 195 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Welch Allyn, Inc.: 3 (https://510kreport.com/company/welch-allyn)
- Burdick Corp.: 2 (https://510kreport.com/company/burdick)
- Mortara Instrument, Inc.: 1 (https://510kreport.com/company/mortara-instrument)
- Dms-Service, LLC: 1 (https://510kreport.com/company/dms-service)
- iRhythm Technologies, Inc.: 1 (https://510kreport.com/company/irhythm-technologies)

## Firms that cite its devices most
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Contec Medical System Co., Ltd.: 1 (https://510kreport.com/company/contec-medical-system)

## Its most-cited devices
- K051730: Matrix Holter System, Model M12 (2005), cited by 1
- K152701: Matrix Mini ECG Monitor (2016), cited by 1

## Recent decisions
- K252840: M12 Telemetry System (May 29, 2026)
- K202456: M5 Recorder (Dec 29, 2020)
- K162463: Matrix Data Management System (May 24, 2017)
- K152701: Matrix Mini ECG Monitor (Apr 22, 2016)
- K051730: Matrix Holter System, Model M12 (Sep 26, 2005)

Source page: https://510kreport.com/company/global-instrumentation