510(k) · Cleared
ClearedInfrared Thermometer: Model YJ600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuhai Yueja Medical Device Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 9, 2024 as substantially equivalent to K200471 (Ningbo Ranor Medical Science & Technology Co., Ltd., 2020) after a 177-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Feb 9, 2024
- Review
- 177 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K171578 (2017). No later device cites it as a predicate yet.
- Root · 3 generations backK171578 Infrared thermometerShenzhen Aeon Technology Co., Ltd. · 2017
- 2 generations backK191251 Infared ThermometerShenzhen Calibeur Industries Co., Ltd. · 2019
- 1 generation backK200471 Infrared Thermometer Model Number RN-60A,RN-60BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020
- This deviceK232473 Infrared Thermometer: Model YJ600Zhuhai Yueja Medical Device Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K171578 | Infrared thermometer | Shenzhen Aeon Technology Co., Ltd. | 2017 | — |
| −2 | K191251 | Infared Thermometer | Shenzhen Calibeur Industries Co., Ltd. | 2019 | — |
| −1 | K200471 | Infrared Thermometer Model Number RN-60A,RN-60B | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K232473 | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K200471 | Infrared Thermometer Model Number RN-60A,RN-60BSummary page 5…mmon name Electronic Thermometer Regulatory Class II Review Panel General Hospital II Predicate Device 510k Number K200471 Trade Name of Device: Infrared Thermometer, Model: RN-60A, RN-60B Regu… | 2020 |
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 7 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232473: Infrared Thermometer: Model YJ600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232473
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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