# K170723: Swaive Thermometer SWT1A

- Pathway: 510(k) (Traditional)
- Applicant: E-Care Technology Co., Ltd.
- Decided: Oct 25, 2018 after 595 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: 1 generation back to K110559 (2012). 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)
- K110559: Avita Infrared Therometer with Bluetooth, Avita Corporation (2012) Summary page 4.

## Indications for use
This device is an electronic clinical thermometer (infrared ear thermometer) to measure and monitor body temperature from auditory canal for people of all ages in a home set environment.

Source page: https://510kreport.com/device/K170723
Methodology: https://510kreport.com/methodology