# K083185: Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1

- Pathway: 510(k) (Traditional)
- Applicant: Cadi Scientific Pte.Ltd
- Decided: Mar 11, 2009 after 133 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914085 (1991). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033534: Vitalsense, Mini-Mitter Co., Inc. (2004) Summary page 1.
- K003326: Funet Amy Mama Body Thermometer, Funai Radio & Communications Corp. (2001) Summary page 1.

## Most influential descendants
- K110015: Vitalsens, Aingeal, V-Pod (2011), 4 descendants of its own
- K132407: Vital Signs Patch System (in Short VSP) (2014), 1 descendant of its own
- K230298: Celsi Monitor (2023), 0 descendants of its own
- K153275: Aingeal Activity System (2016), 0 descendants of its own
- K151835: Vital Signs Patch System (2016), 0 descendants of its own

## Indications for use
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes. The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information. Warning: This equipment measures and reports abdominal surface temperature - where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.

Source page: https://510kreport.com/device/K083185
Methodology: https://510kreport.com/methodology