510(k) · Cleared
ClearedCelsi Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hadleigh Health Technologies · FLL Continuous Measurement Thermometer
Cleared on Aug 16, 2023 as substantially equivalent to K083185 (Cadi Scientific Pte.Ltd, 2009) after a 195-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Aug 16, 2023
- Review
- 195 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914085 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 3 generations backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- 2 generations backK033534 VitalsenseMini-Mitter Co., Inc. · 2004
- 1 generation backK083185 Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG…Cadi Scientific Pte.Ltd · 2009
- This deviceK230298 Celsi MonitorHadleigh Health Technologies · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −3 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| −2 | K033534 | Vitalsense | Mini-Mitter Co., Inc. | 2004 | — |
| −1 | K083185 | Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model… | Cadi Scientific Pte.Ltd | 2009 | — |
| 0 (this device) | K230298 | Celsi Monitor | Hadleigh Health Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083185 | Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1Summary page 4…The Celsi Monitor is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K083185 Cadi SmartSense Wireless Temperature Monitoring… | 2009 |
| † | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient… | 2006 |
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.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K083185.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230298: Celsi Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230298
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026