# K022542: Philips Baby Thermometer Set (SBC SC530)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Consumer Electronics
- Decided: Aug 20, 2002 after 19 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 K844273 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952073: Paci-Temp, Pacifier with Digital Thermometer, Intelligent Product Limited Co. (1995) Summary page 1.
- K961357: Pro-Flex, Digital Thermometer with Flexible Probe, Intelligent Product Limited Co. (1996) Summary page 1.

## Indications for use
The Philips Baby Thennometer Set is intcnded for determination of a baby’s oral, rectal, or axillary temperature. The set contains three items: A pacifier thermometer to detect baby’s oral temperature. An ordinary pacifier can be used as a daily use pacifier to help accustom the baby to the shape of the pacifier-thermometer. A digital flexible-tip thermometer to detect baby’s rectal or underarm (axillary) temperature.

Source page: https://510kreport.com/device/K022542
Methodology: https://510kreport.com/methodology