# K021048: Thermometer Models ST8631

- Pathway: 510(k) (Traditional)
- Applicant: Z7 International
- Decided: Apr 22, 2002 after 21 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.
50 later devices descend from it; 4 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022188: Radianalyzer, Model 12710 (2002), 46 descendants of its own
- K042628: Modification to: Radianalyzer, Model 12711 (2005), 26 descendants of its own
- K031662: Pressure Wire Sensor, Models 12004/12304 (2003), 26 descendants of its own
- K092105: Radianalyzer Xpress (2009), 25 descendants of its own
- K062769: Pressurewire Certus, Models 12006 and 12306 (2006), 25 descendants of its own

## Indications for use
The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.

Source page: https://510kreport.com/device/K021048
Methodology: https://510kreport.com/methodology