# K210924: e-Celsius Medical System

- Pathway: 510(k) (Traditional)
- Applicant: Bodycap
- Decided: Jun 28, 2023 after 821 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
e-Celsius Medical System is indicated for the measurement of core body temperature in patients for whom accurate continuous core body temperatures are clinically necessary for periods exceeding six (6) hours and with whom rectal catheters are not appropriate. e-Celsius Medical System can only be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of and ingestible thermometer and determined that the risk is clinically justified versus an oral thermometer or- rectal catheter. e-Celsius Medical System is indicated for patients 18 years or older as long as their body weight is above 80 pounds. e-Celsius Medical System is not indicated for patients with special needs, esophageal or swallowing disorders, who are psychologically unsound, or have disabilities which may make the patient unable to swallow the device for any reason, these patients should be deemed ineligible for this device. e-Celsius Medical System is a prescription use device primarily (e.g., initial setup, final data assessment, reprocessing, etc.) indicated for use in clinical environments (e.g., hospitals, hospice, clinics, medical offices, outpatient care centers, ambulatory surgical centers, nursing facilities, urgent care, etc.) with some recording and storage being performed in the home environment.

Source page: https://510kreport.com/device/K210924
Methodology: https://510kreport.com/methodology