510(k) · Cleared
ClearedInfrared Thermometer Model Number RN-50A,RN-50B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Ranor Medical Science & Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jul 16, 2020 as substantially equivalent to K191251 (Shenzhen Calibeur Industries Co., Ltd., 2019) after a 133-day review. Its family tree reaches back 2 generations to 2017. 5 later devices descend from it.
- Decided
- Jul 16, 2020
- Review
- 133 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K171578 (2017). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK171578 Infrared thermometerShenzhen Aeon Technology Co., Ltd. · 2017
- 1 generation backK191251 Infared ThermometerShenzhen Calibeur Industries Co., Ltd. · 2019
- This deviceK200578 Infrared Thermometer Model Number RN-50A,RN-50BNingbo Ranor Medical Science & Technology Co., Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK253436 c-med0 alphaCosinuss GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK231116 Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK222330 The Heart SeatCasana Care, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021 · cites it directly4descendants
- K212975MedWandMedwand Solutions, Inc. · 2022 · 2 generations on1descendant
- K253436c-med0 alphaCosinuss GmbH · 2026 · 3 generations on0descendants
- K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. · 2024 · 2 generations on0descendants
- K222330The Heart SeatCasana Care, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K171578 | Infrared thermometer | Shenzhen Aeon Technology Co., Ltd. | 2017 | — |
| −1 | K191251 | Infared Thermometer | Shenzhen Calibeur Industries Co., Ltd. | 2019 | — |
| 0 (this device) | K200578 | Infrared Thermometer Model Number RN-50A,RN-50B | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020 | — |
| +1 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | — |
| +2 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
| +3 | K253436 | c-med0 alpha | Cosinuss GmbH | 2026 | — |
| +2 | K231116 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024 | — |
| +2 | K222330 | The Heart Seat | Casana Care, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K191251 | Infared ThermometerSummary page 4…pital 4.0 Predicate Device Information Manufacturer: Shenzhen Calibeur Industries Co., Ltd. Device: Infrared Thermometer, Model DT-8836T, DT-8836P 510(k) number: K191251 6-1 510(k) Summary 5.0 Device Description The Infrared Thermo… | 2019 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210086 | Vitals360 Multi-Vitals Mobile Monitor | 2021 | 4 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210086 (Vocare, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K191251.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 one month old and above. 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/K200578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200578: Infrared Thermometer Model Number RN-50A,RN-50B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200578
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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