# K251508: Telemetry Monitor (iT30, iT50)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Aug 6, 2026 after 447 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
Longest line of descent: 30 generations back to K941811 (1994). 192 ancestors in all.
No later device cites it as a predicate yet.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193391: BeneVision Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2020) Summary page 6.

## Indications for use
The iT30 and iT50 Telemetry Monitor are intended for use on Adult and Pediatric patients (over three years old) to monitor monitor physiological parameters include ECG, SpO2, PR, NIBP (Applicable to iT50 only), and Skin TEMP. The physiological data can be analyzed, alarmed, stored locally on the monitor, and the Edan Central Monitoring System can configure, display and review the physiological parameters from the iT30 and iT50 Telemetry Monitor. The arrhythmia detection and ST Segment analysis of ECG are intended for adult patients. The SpO2 and PR are used under no motion conditions. The NIBP is used under no motion conditions for patients over 12 years old and excluding pregnant women. The iT30 and iT50 Telemetry Monitor must be used by professional trained clinical medical staff in healthcare facilities.

Source page: https://510kreport.com/device/K251508
Methodology: https://510kreport.com/methodology