# K212346: Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Medical Electronics Co., Ltd.
- Decided: May 5, 2022 after 281 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: 6 generations back to K011291 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182597: Infrared thermometer, Shenzhen Pango Electronic Co., Ltd. (2019) Summary page 6.

## Indications for use
PG-IRT1612 & PG-IRT1618 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. The device can be used on people of all ages at home or in hospital environment. PG-IRT1613 & PG-IRT1615 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 at home or in hospital environment.

Source page: https://510kreport.com/device/K212346
Methodology: https://510kreport.com/methodology