# K011254: Ear Thermometer, Models ST613C and ST613F

- Pathway: 510(k) (Traditional)
- Applicant: Mesure Technology
- Decided: Jul 10, 2001 after 77 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042627: Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65 (2004), 1 descendant of its own
- K102935: Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818 and TM818A (2011), 0 descendants of its own
- K102934: Infrared Ear Thermometer, Model IR-04MT (2011), 0 descendants of its own
- K080981: Ear Thermometer, Models ST66 and ST67 (2008), 0 descendants of its own
- K070578: Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared Thermometer (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K011254
Methodology: https://510kreport.com/methodology