510(k) · Cleared
ClearedInfared Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Calibeur Industries Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Oct 15, 2019 as substantially equivalent to K171578 (Shenzhen Aeon Technology Co., Ltd., 2017) after a 159-day review. Its family tree reaches back 1 generation to 2017. 14 later devices descend from it.
- Decided
- Oct 15, 2019
- Review
- 159 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171578 (2017). 14 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK171578 Infrared thermometerShenzhen Aeon Technology Co., Ltd. · 2017
- This deviceK191251 Infared ThermometerShenzhen Calibeur Industries Co., Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK200578 Infrared Thermometer Model Number RN-50A,RN-50BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK203707 Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603Shenzhen Zhengkang Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK200471 Infrared Thermometer Model Number RN-60A,RN-60BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K200578Infrared Thermometer Model Number RN-50A,RN-50BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020 · cites it directly5descendants
- K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021 · 2 generations on4descendants
- K212975MedWandMedwand Solutions, Inc. · 2022 · 3 generations on1descendant
- K203707Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603Shenzhen Zhengkang Technology Co., Ltd. · 2021 · cites it directly1descendant
- K200471Infrared Thermometer Model Number RN-60A,RN-60BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171578 | Infrared thermometer | Shenzhen Aeon Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K191251 | Infared Thermometer | Shenzhen Calibeur Industries Co., Ltd. | 2019 | — |
| +1 | K200578 | Infrared Thermometer Model Number RN-50A,RN-50B | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020 | — |
| +2 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | — |
| +3 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
| +1 | K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | Shenzhen Zhengkang Technology Co., Ltd. | 2021 | — |
| +1 | K200471 | Infrared Thermometer Model Number RN-60A,RN-60B | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K171578 | Infrared thermometerSummary page 4…21CFR 880.2910 / Clinical electronic thermometer / Submission type Traditional 510(K) Product Code FLL 4. Predicate Device 510(k) Number: K171578 Manufacturer: Shenzhen Aeon Technology Co., Ltd. Device name/ Model: Infrared thermometer/ A200 5. Device Description The Infr… | 2017 |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200578 | Infrared Thermometer Model Number RN-50A,RN-50B | 2020 | 5 |
| K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | 2021 | 1 |
| K200471 | Infrared Thermometer Model Number RN-60A,RN-60B | 2020 | 1 |
| K202687 | Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 | 2021 | 0 |
| K202368 | Infrared Thermometer | 2021 | 0 |
| K203747 | Non-Contact Forehead Thermometer (Models UT306H & UT308H) | 2021 | 0 |
| K203656 | Non-Contact Forehead Thermometer (UT30H) | 2021 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K200578 (Ningbo Ranor Medical Science & Technology Co., Ltd., 2020) has gone furthest, with 5 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. 2019, 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?
The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191251: Infared Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191251
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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