# K100843: Abreu, Model 700

- Pathway: 510(k) (Traditional)
- Applicant: Brain Tunnelgenix Technologies Corp
- Decided: Aug 17, 2010 after 145 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 K910718 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910718: Ysi Precision 4000 Thermometer, Yellow Springs Instrument Co., Inc. (1991) Summary page 1.

## Indications for use
The instrument is for the continuous monitoring of skin temperature during surgical procedures, recovery room, intensive care, and general patient monitoring. The unit will alert the patient and/or hospital personnel when the monitored temperature exceeds or falls below pre-selected levels.

Source page: https://510kreport.com/device/K100843
Methodology: https://510kreport.com/methodology