# K103617: Digital Forehead Thermometer

- Pathway: 510(k) (Special)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Apr 4, 2011 after 115 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902624 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070491: Digital Forehead Thermometer, Model# KD-2200, K-Jump Health Co., Ltd. (2007) Summary page 1.

## Recalls of this device
- Nov 12, 2015 · Class II · Z-0412-2016: An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.

## Indications for use
K-jump Health Ca, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.

Source page: https://510kreport.com/device/K103617
Methodology: https://510kreport.com/methodology