# K041516: Digital Thermometer, Models MT-XX8 and MT-XX9

- Pathway: 510(k) (Traditional)
- Applicant: Vega Technologies, Inc.
- Decided: Sep 8, 2004 after 96 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 K021048 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021048: Thermometer Models ST8631, Z7 International (2002) Summary page 1.

## Recalls of this device
- Nov 23, 2011 · Not classified · Z-0506-2012: The thermometers have been reported to have inaccurate readings

## Indications for use
The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.

Source page: https://510kreport.com/device/K041516
Methodology: https://510kreport.com/methodology