510(k) · Cleared
Clearede-Celsius Medical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodycap · FLL Continuous Measurement Thermometer
Cleared on Jun 28, 2023 after an 821-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 28, 2023
- Review
- 821 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (198 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K210924 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210924: e-Celsius Medical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210924
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026