# K101198: Csi Managed Health System Model: Csi Model 9K

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Screening, Inc.
- Decided: Aug 4, 2010 after 97 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: 8 generations back to K910772 (1991). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093389: Csi Model 5K Managed Health System Kiosk, Computerized Screening, Inc. (2009) Summary page 1.
- K090294: Fora IR22 Ear Thermometer, Model TD-1262, Taidoc Technology Corporation (2009) Summary page 1.
- K063008: Health Check Kiosk, Xperex Corporation (2007) Summary page 1.

## Most influential descendants
- K153600: Consult Station TS (2017), 0 descendants of its own

## Indications for use
CSI Model 9K Managed Health System Kiosk is an automated non invasive screening device intended for voluntary use by the general public.. The device measures systolic and diastolic blood pressure, pulse and if optionally equipped, weight and temperature. Users may also manually enter or download blood glucose level. Data from the Model 9K may be stored by the user for tracking purposes. It is not a diagnostic device, and only fuirnishes data so users can consult their personal physicians. The device is intended for users fourteen years or older. Children under the age of fourteen must be accompanied by an adult.

Source page: https://510kreport.com/device/K101198
Methodology: https://510kreport.com/methodology