# K182597: Infrared thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Electronic Co., Ltd.
- Decided: Apr 3, 2019 after 195 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 K011291 (2001). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152748: Braun Thermoscan PRO 6000 Ear Thermometer, Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) (2016) Summary page 6.
- K163516: Braun No Touch + Forehead NTF3000 Thermometer, Kaz USA, Inc., A Helen of Troy Company (2017) Summary page 6.

## Most influential descendants
- K212346: Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 (2022), 0 descendants of its own
- K202591: Body Infrared Thermometer HT-820D (2021), 0 descendants of its own
- K201980: Infrared Thermometer (2020), 0 descendants of its own

## Indications for use
PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal. PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages.

Source page: https://510kreport.com/device/K182597
Methodology: https://510kreport.com/methodology