510(k) · Cleared
ClearedM12 Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Instrumentation, LLC · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 29, 2026 after a 266-day review. The FDA summary names its predicate without a number.
- Decided
- May 29, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Infinity Central Station Wide, Infinity M300, Infinity M300+ Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The M12 Telemetry System is intended for use by trained clinical research healthcare professionals for the purpose of centralized monitoring of adult and adolescent patients (11 to 17 years) participating in clinical studies within clinical research facilities. Centralized monitoring involves the display and management of data from networked patient telemetry transmitters including the annunciation of visual and audible physiologic parameter alarms at a…
Read the full statement (170 words)
The M12 Telemetry System is intended for use by trained clinical research healthcare professionals for the purpose of centralized monitoring of adult and adolescent patients (11 to 17 years) participating in clinical studies within clinical research facilities. Centralized monitoring involves the display and management of data from networked patient telemetry transmitters including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
The M12 Telemetry System with resting 12-lead ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and adolescent patients when connected to a transmitter with 12-Lead ECG monitoring enabled.
The M12RT Telemetry Transmitter is intended for use with the M12A Telemetry Central Station to monitor ECG on ambulatory and non-ambulatory adult and adolescent patients using wireless communication over the M12 telemetry network.
The M12RT Telemetry Transmitter can deliver ECG data using a 10-lead cable.
The M12 Telemetry System is not intended for general patient monitoring (e.g., hospitals, intensive care units, operating room, and other healthcare facilities except for clinical research).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252840: M12 Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252840
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026