# K012136: Avita Agil IT 101 Instant Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Sep 10, 2001 after 63 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: 2 generations back to K943695 (1995). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990168: Microlife IT2CA1, Microlife Systems AG (1999) Summary page 1.

## Most influential descendants
- K031958: Microlife Instant Digital Electronic Thermometer, Model QT1JA1 (2003), 8 descendants of its own
- K043110: Microlife Instant Digital Electronic Thermometer, Model MT18L1 (2004), 5 descendants of its own
- K152975: VDT985US Vicks SmartTemp Thermometer (2016), 3 descendants of its own
- K180131: Vicks RapidRead Digital Thermometer (2018), 2 descendants of its own
- K202791: iHealth Clinical Digital Thermometer (2021), 1 descendant of its own

## Indications for use
AVIiTA Agil IT101 Instant Lvigital Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm, by consumers in the home. AvViTA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either rapid mode (4-seconds orally, 6-seconds rectally and under the arm -- Predicative Temperature), or standard mode(actual determination of temperature), The device is to used and installed by people exception of handicapped persons and children. The device is to used in the ENVIRONMENT of room temperature & normal environment condition.

Source page: https://510kreport.com/device/K012136
Methodology: https://510kreport.com/methodology