# K161056: Telemetry Transmitter

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 3, 2017 after 295 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K941811 (1994). 243 ancestors in all.
No later device cites it as a predicate yet.
1 of 244 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016), Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2014) Summary page 5.
- K131971: IM60/IM70 Patient Monitor, Edan Instruments, Inc. (2014) Summary page 5.

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1155-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
- Nov 17, 2017 · Class II · Z-1256-2020: Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

## Indications for use
The iT20 telemetry transmitter is intended to monitor physiological parameters including: ECG, oxygen saturation of arterial blood (SpO2) and pulse rate (PR) for adults and pediatric patients. The iT20 requires the EDAN MFM-CMS (Central Monitoring Station) to provide full functionality of the device. The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.).

Source page: https://510kreport.com/device/K161056
Methodology: https://510kreport.com/methodology