# K023500: Digital Clinical Thermometer, Model Baby Temp/WL-3305 and Baby Temp (+) /WL-3306

- Pathway: 510(k) (Traditional)
- Applicant: Innovatech, Inc.
- Decided: Dec 13, 2002 after 56 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 K010238 (2001). 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)
- K010238: Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+, Actherm, Inc. (2001) Summary page 1.

## Indications for use
The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TIIMP(+) WL-3306 are the battery-operated electronic devices with intended use of measuring humari body temperature precisely. It can be measurement of oral, axially and rectal temperature.

Source page: https://510kreport.com/device/K023500
Methodology: https://510kreport.com/methodology