# K100495: Philips Avent Digital Thermometer Set, Model SCH540

- Pathway: 510(k) (Traditional)
- Applicant: Philips Electronics UK Limited
- Decided: Jun 22, 2010 after 123 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items: * A pacifier thermometer to detect baby's oral temperature. * An ordinary pacifier that can be used as a daily used regular pacifier. * A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

Source page: https://510kreport.com/device/K100495
Methodology: https://510kreport.com/methodology