# K990168: Microlife IT2CA1

- Pathway: 510(k) (Abbreviated)
- Applicant: Microlife Systems AG
- Decided: Feb 25, 1999 after 37 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 K943695 (1995). 1 ancestor in all.
10 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)
- K943695: Suretemp, Advanced Bioresearch Assoc. (1995) Summary page 1.

## Most influential descendants
- K012136: Avita Agil IT 101 Instant Digital Thermometer (2001), 9 descendants of its own
- 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

## Indications for use
The IT2CA1 is used in a home use environment tQ make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.

Source page: https://510kreport.com/device/K990168
Methodology: https://510kreport.com/methodology