# K252840: M12 Telemetry System

- Pathway: 510(k) (Traditional)
- Applicant: Global Instrumentation, LLC
- Decided: May 29, 2026 after 266 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Infinity Central Station Wide, Infinity M300, Infinity M300+: named in the summary without a submission number

## Indications for use
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).

Source page: https://510kreport.com/device/K252840
Methodology: https://510kreport.com/methodology