# K983887: UP-Grade and UP-Grade Pro

- Pathway: 510(k) (Traditional)
- Applicant: Medisim, Ltd.
- Decided: Feb 12, 1999 after 102 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: 1 generation back to K902624 (1990). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964643: Suretemp, Diatek Instruments, Inc. (1997) Summary page 2.
- K902624: BD Flexible Digital Thermometer, Bd Becton Dickinson Vacutainer Systems Preanalytic (1990) Summary page 2.

## Most influential descendants
- K032362: UP-Grade Forehead Thermometer (2003), 5 descendants of its own
- 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

## Recalls of this device
- Oct 25, 2005 · Not classified · Z-0466-06: Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.

## Indications for use
The Up-Grade is an over-the-counter, non-sterile, reusable clinical thermometer intended for the determination of oral, rectal, and axillary body temperature determination in humans.

Source page: https://510kreport.com/device/K983887
Methodology: https://510kreport.com/methodology