510(k) · Cleared
ClearedInfrared Ear Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiant Innovation, Inc. · FLL Continuous Measurement Thermometer
Cleared on Dec 29, 2010 as substantially equivalent to K011059 (Radiant Innovation, Inc., 2001) after a 70-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Dec 29, 2010
- Review
- 70 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011059 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- This deviceK103097 Infrared Ear ThermometerRadiant Innovation, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK113833 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK153135 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK181919 Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK170538 RVS-100 Vital Signs MonitorRudolf Riester GmbH · 2017
Most influential descendants
Showing 4 of 4 · See all- K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2012 · cites it directly3descendants
- K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2016 · 2 generations on2descendants
- K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2019 · 3 generations on0descendants
- K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| 0 (this device) | K103097 | Infrared Ear Thermometer | Radiant Innovation, Inc. | 2010 | — |
| +1 | K113833 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2012 | — |
| +2 | K153135 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
| +3 | K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019 | — |
| +3 | K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K011059 | Infared Ear Thermometer, Model TH8 SeriesSummary page 1…(510(k)#: K051269), THXXN series (510(k)#: K040377), THi series (510(k)#: K030324), TH88 series (510(k)#: K020504) and TH8 series (510(k)#: K011059). 4. Device Description: The Radiant Innovation Inc., Infrared Ear Thermometer, Models TBK09, IRT 30… | 2001 |
| † | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | 2009 |
| † | K983295 | Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520 | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113833 | Vital Signs Monitor | 2012 | 3 |
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?
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103097: Infrared Ear Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103097
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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