# K240220: Aulisa Temperature Module (TM0002)

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
- Decided: Sep 27, 2024 after 245 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: 10 generations back to K010462 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181013: Fever Scout, VivaLNK, Inc. (2018) Summary page 5.

## Indications for use
Aulisa Temperature Module (TM0002) is a battery-operated electronic device with indication for use in continuously measuring and monitoring armpit body temperature of adults, pediatrics, and infants and transmission of the measuring result via wireless signal. Aulisa Temperature Module (TM0002) is a non-invasive and reusable device for single patient use with intended environments of use are hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Temperature Module (TM0002) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

Source page: https://510kreport.com/device/K240220
Methodology: https://510kreport.com/methodology