# K142476: Master Caution Device MCD

- Pathway: 510(k) (Traditional)
- Applicant: Healthwatch, Ltd.
- Decided: Feb 17, 2015 after 167 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K882803 (1988). 34 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113514: Smartheart, Shl Telemedicine International, Ltd. (2012) Summary page 5.
- K132764: Motion Watch and Pro-Diary, Camntech, Ltd. (2014) Summary page 5.
- K083287: Avivo Mobile Patient Management System, Corventis, Inc. (2009) Summary page 5.
- K090610: Hospira Vital Signs Wireless Monitoring System, Hospira, Inc. (2009) Summary page 5.

## Most influential descendants
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K212160: SimpleSENSE Platform (2021), 1 descendant of its own
- K243981: Hexoskin Medical System (7100-00016) (2025), 0 descendants of its own
- K232053: SimpleSense-BP, SimpleSense-BP Software Application (2023), 0 descendants of its own

## Indications for use
Master Caution Device (MCD) is intended to condition an electrocardiographic signal, so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Master Caution Device (MCD) is designed to be used by a patient to transmit a 12 lead ECG, posture and motion , respiration and skin temperature (IR) signals, in near real-time to enable review at a physician's office, hospital or other remote medical receiving center. Master Caution Device (MCD) target population is adults above the age of 21.

Source page: https://510kreport.com/device/K142476
Methodology: https://510kreport.com/methodology