# K023412: Thermo Buddy, Models TB-100, TB-110, TB-120

- Pathway: 510(k) (Traditional)
- Applicant: Hubdic Co., Ltd.
- Decided: Apr 9, 2003 after 180 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: 1 generation back to K922344 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983295: Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520, Braun AG (1999) Summary page 1.
- K922344: Omron Tympanic Thermometer MC-500, Omron Healthcare, Inc. (1993) Summary page 1.

## Indications for use
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used at home.

Source page: https://510kreport.com/device/K023412
Methodology: https://510kreport.com/methodology