# K120412: 3M Spoton Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Arizant Healthcare, Inc.
- Decided: May 30, 2012 after 110 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760948 (1976). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760948: Thermo Finer Coretemp, Terumo America, Inc. (1976) Summary page 2.

## Most influential descendants
- K150160: Temple Touch Pro (TTP) Non-invasive temperature monitoring system (2015), 0 descendants of its own

## Recalls of this device
- Oct 17, 2017 · Class II · Z-0114-2018: During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients a

## Indications for use
Measure, monitor, and trend body temperature of adult and pediatric patients.

Source page: https://510kreport.com/device/K120412
Methodology: https://510kreport.com/methodology