# K153600: Consult Station TS

- Pathway: 510(k) (Traditional)
- Applicant: H4D Sas
- Decided: Mar 17, 2017 after 457 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910772 (1991). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101198: Csi Managed Health System Model: Csi Model 9K, Computerized Screening, Inc. (2010) Summary page 5.
- K903134: Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C, Omron Marshall Products, Inc. (1991) Summary page 5.
- K160816: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10), Nexmed Technology Co., Ltd. (2016). Cleared while this submission was under review Summary page 5.

## Indications for use
The Consult Station TS is intended to be used by the general public to perform a health check, including the measurement of certain vital signs (weight, BMI, temperature, blood pressure and pulse rate). The lay user autonomously self-performs all the measurements listed above. Using an audio-video conferencing feature incorporated in the Consult Station TS to connect with a healthcare professional remotely, it is possible to perform additional examinations: ENT (Ear, Nose, Throat) and skin examinations, auscultations sounds and blood oxygen level. The lay user and the healthcare professional are able to see and to interact each other. The Consult Station TS is not intended for diagnostic use. Lay users should consult their personal physician if they have concerns regarding the results of their health check. The Consult Station TS is intended for lay users of fourteen (14) years old or older. The Consult Station TS is not intended for children under the age of fourteen. The Consult Station can be deployed in indoor public areas, such as: pharmacies, senior living communities, shopping centers, corporations, etc.

Source page: https://510kreport.com/device/K153600
Methodology: https://510kreport.com/methodology