# K032362: UP-Grade Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Medisim, Ltd.
- Decided: Dec 4, 2003 after 126 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 K902624 (1990). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983887: UP-Grade and UP-Grade Pro, Medisim, Ltd. (1999) Summary page 2.
- K012217: M5T Instant Fever Thermometer, Medisim, Ltd. (2001) Summary page 2.
- K002712: Thermo Tek IR Forehead Thermometer, Model 718F, Saat, Ltd. (2001) Summary page 2.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001). Our reading of the summary gave K001291, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.

## Most influential descendants
- K103839: Behind Ear Gentle Touch Thermometer (2011), 1 descendant of its own
- K070491: Digital Forehead Thermometer, Model# KD-2200 (2007), 1 descendant of its own
- K051422: Dual Mode UP-Grade Forehead/Underarm Thermometer Device (2005), 1 descendant of its own
- K131155: UGFT3; FHT7 (2013), 0 descendants of its own
- K103617: Digital Forehead Thermometer (2011), 0 descendants of its own

## Indications for use
The UP-GRADE FOREHEAD THERMOMETER is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead as measurement site.

Source page: https://510kreport.com/device/K032362
Methodology: https://510kreport.com/methodology