# K230298: Celsi Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Hadleigh Health Technologies
- Decided: Aug 16, 2023 after 195 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: 4 generations back to K914085 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083185: Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1, Cadi Scientific Pte.Ltd (2009) Summary page 4.

## Indications for use
Celsi Monitor is intended for use in hospitals under a clinician’s supervision or at their direction to assist nurses in continuous temperature monitoring of neonates. The device measures abdominal skin temperature through direct contact.

Source page: https://510kreport.com/device/K230298
Methodology: https://510kreport.com/methodology