510(k) · Cleared
ClearedRemote Infrared Thermometer, Model RC002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rycom Electron Technology Limited · FLL Continuous Measurement Thermometer
Cleared on Oct 8, 2009 after a 238-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 8, 2009
- Review
- 238 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK090361 Remote Infrared Thermometer, Model RC002Rycom Electron Technology Limited · 2009
- Descendant · cites it directly · 0 of its ownK152905 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch…Arc Devices Limited · 2016
- Descendant · cites it directly · 0 of its ownK130231 Non-Contact Infrared ThermometerJinxinbao Electronic Co.,Ltd · 2013
- Descendant · cites it directly · 0 of its ownK112929 Thermoflash (TM) Infrared ThermometerVisiomed Group SA · 2011
Most influential descendants
Showing 3 of 3 · See all- K152905ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch ThermometerArc Devices Limited · 2016 · cites it directly0descendants
- K130231Non-Contact Infrared ThermometerJinxinbao Electronic Co.,Ltd · 2013 · cites it directly0descendants
- K112929Thermoflash (TM) Infrared ThermometerVisiomed Group SA · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090361 | Remote Infrared Thermometer, Model RC002 | Rycom Electron Technology Limited | 2009 | — |
| +1 | K152905 | ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer | Arc Devices Limited | 2016 | — |
| +1 | K130231 | Non-Contact Infrared Thermometer | Jinxinbao Electronic Co.,Ltd | 2013 | — |
| +1 | K112929 | Thermoflash (TM) Infrared Thermometer | Visiomed Group SA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K152905 (Arc Devices Limited, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
doctor in clinic as reference,
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090361: Remote Infrared Thermometer, Model RC002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090361
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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