# K242964: Celsi Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Hadleigh Health Technologies
- Decided: Jun 20, 2025 after 267 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K912051 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152266: Altrix Precision Temperature Management System, Stryker Medical (2016) Summary page 5.

## Indications for use
Celsi Warmer is intended for use in hospitals under a clinician’s supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates. a. Maintain pre-set body temperature as determined by the physician. b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. c. Monitoring and controlling patient temperature.

Source page: https://510kreport.com/device/K242964
Methodology: https://510kreport.com/methodology