510(k) · Cleared
ClearedInfrared thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Aeon Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Nov 30, 2017 after a 183-day review. The FDA summary names no predicate by number. 15 later devices descend from it.
- Decided
- Nov 30, 2017
- Review
- 183 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK171578 Infrared thermometerShenzhen Aeon Technology Co., Ltd. · 2017
- Descendant · cites it directly · 14 of its ownK191251 Infared ThermometerShenzhen Calibeur Industries Co., Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK200578 Infrared Thermometer Model Number RN-50A,RN-50BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK203707 Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603Shenzhen Zhengkang Technology Co., Ltd. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K191251Infared ThermometerShenzhen Calibeur Industries Co., Ltd. · 2019 · cites it directly14descendants
- K200578Infrared Thermometer Model Number RN-50A,RN-50BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020 · 2 generations on5descendants
- K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021 · 3 generations on4descendants
- K212975MedWandMedwand Solutions, Inc. · 2022 · 4 generations on1descendant
- K203707Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603Shenzhen Zhengkang Technology Co., Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K171578 | Infrared thermometer | Shenzhen Aeon Technology Co., Ltd. | 2017 | — |
| +1 | K191251 | Infared Thermometer | Shenzhen Calibeur Industries Co., Ltd. | 2019 | — |
| +2 | K200578 | Infrared Thermometer Model Number RN-50A,RN-50B | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020 | — |
| +3 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | — |
| +4 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
| +2 | K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | Shenzhen Zhengkang Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191251 | Infared Thermometer | 2019 | 14 |
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, K191251 (Shenzhen Calibeur Industries Co., Ltd., 2019) has gone furthest, with 14 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. 2017, 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 | — |
https://510kreport.com/device/K171578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171578: Infrared thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171578
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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