Global Instrumentation, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Global Instrumentation, LLC” (first 2005, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 214 days. Since 2017 the median was 264 days, against 176 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 214 |
| 2017 | 1 | 264 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 124 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 266 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Global Instrumentation, LLC took a median 264 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Global Instrumentation, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252840 | M12 Telemetry System | MHX | 2026-05-29 | 266 |
| K202456 | M5 Recorder | DSH | 2020-12-29 | 124 |
| K162463 | Matrix Data Management System | DXN | 2017-05-24 | 264 |
| K152701 | Matrix Mini ECG Monitor | DSI | 2016-04-22 | 214 |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | 2005-09-26 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Global Instrumentation, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Global Protection Corp. (10 510(k)s)
- Global Medical Prods, Inc. (9 510(k)s)
- Global Endoscopy, Inc. (7 510(k)s)
- Global Medical Products, Ltd. (5 510(k)s)
- Global Treasure Industries , Ltd. (5 510(k)s)
- Global Fabtech Wheelchair (Shanghai) Co., Ltd. (4 510(k)s)
- Global USA Distribution, LLC (4 510(k)s)
- Global Healthcare, Inc. (3 510(k)s)
- Global Manufacturing Technology (3 510(k)s)
- Global Orthopaedic Technology, USA, Inc. (3 510(k)s)
- Global TV Concepts, Ltd. (3 510(k)s)
- Global Blood Resources, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Global Instrumentation, LLC?
FDA lists 5 510(k) clearances under the applicant name “Global Instrumentation, LLC” (first 2005, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Global Instrumentation, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Global Instrumentation, LLC is 214 days. Since 2017: 264 days, versus 176 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Global Instrumentation, LLC?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 1); DSI (Detector And Alarm, Arrhythmia, 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 5 Global Instrumentation, LLC clearances with predicates and recalls
- Run predicate analysis for product code DSH, Global Instrumentation, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.