# K100563: Geon Rapid Digital Thermometer Model: MT-B117, MT-B127, MT-B130, MT-B132FA

- Pathway: 510(k) (Traditional)
- Applicant: Geon Corporation
- Decided: Jun 2, 2010 after 93 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is an digital thermometers intended for the intermittent measurement of human body temperature either in oral, rectal and axillaries (underarm), by consumers in the home for people of all ages.

Source page: https://510kreport.com/device/K100563
Methodology: https://510kreport.com/methodology