# K033534: Vitalsense

- Pathway: 510(k) (Traditional)
- Applicant: Mini-Mitter Co., Inc.
- Decided: Apr 22, 2004 after 164 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: 2 generations back to K914085 (1991). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991045: Mini-Logger Series 2000, Mini-Mitter Co., Inc. (1999) Summary page 1.

## Most influential descendants
- K083185: Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1 (2009), 6 descendants of its own
- 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
- K102499: Duofertility (2011), 1 descendant of its own
- K230298: Celsi Monitor (2023), 0 descendants of its own

## Indications for use
VitalSense®can be used in any setting where physiological body core and skin temperature are used to further the understanding of body function. The device can be used for simultaneous assessment of core body temperature, dermal surface temperature, or ambient temperatures that require logging of data over time with subsequent conversion, display, and analysis of the aforementioned parameters. VitalSense® may be used in any instance where quantifiable analysis of temperature data is desirable.

Source page: https://510kreport.com/device/K033534
Methodology: https://510kreport.com/methodology