# K172889: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pacom Medical Instruments Co., Ltd.
- Decided: May 25, 2018 after 246 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: 5 generations back to K010462 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102947: Non-Contact Infrared Thermometer, K-Jump Health Co., Ltd. (2011) Summary page 5.

## Indications for use
The Infrared thermometer Model PC868 can measure body temperature from the forehead of infants and adults without contact to the human body, it can be used by consumers in household environment and by doctors in the clinic.

Source page: https://510kreport.com/device/K172889
Methodology: https://510kreport.com/methodology