# K012217: M5T Instant Fever Thermometer

- Pathway: 510(k) (Special)
- Applicant: Medisim, Ltd.
- Decided: Aug 1, 2001 after 16 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Up-Grade Thermometer: named in the summary without a submission number
- (no number) Up-Grade Pro Thermometer: named in the summary without a submission number

## 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

## Indications for use
The MS5T is 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/K012217
Methodology: https://510kreport.com/methodology