510(k) · Cleared
ClearedEar Thermometer, Model ET001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Berrcom Medical Device Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 18, 2022 as substantially equivalent to K191570 (Guangzhou Berrcom Medical Device Co., Ltd., 2019) after a 148-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Feb 18, 2022
- Review
- 148 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011059 (2001). 11 ancestors in all, the oldest K011291 (2001). No later device cites it as a predicate yet.
- Root · 7 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- 6 generations backK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
- 5 generations backK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
- 4 generations backK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
- 3 generations backK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
- 2 generations backK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
- 1 generation backK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019
- This deviceK213079 Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| −6 | K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | Radiant Innovation, Inc. | 2003 | — |
| −5 | K040377 | Rii Infrared Ear Thermometer, Models Thxxn Series | Radiant Innovation, Inc. | 2004 | — |
| −4 | K051269 | Rii Infrared Ear Thermometer, Models TH00XY Series | Radiant Innovation, Inc. | 2005 | — |
| −3 | K063185 | Rii Infrared Ear Thermometer, Models TH5XY Series | Radiant Innovation, Inc. | 2006 | — |
| −2 | K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. | 2017 | — |
| −1 | K191570 | Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd. | 2019 | — |
| 0 (this device) | K213079 | Ear Thermometer, Model ET001 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K191570 | Infrared Thermometer Model MD-H30Summary page 5…e: Infrared Thermometer Model MD-H30 Model: MD-H30 Page 1 of 6 510(K) Number: K191570 Product Code: FLL 4. Device Description The Ear Thermometer, model of ET001 is a hand-held, battery powered infrared t… | 2019 |
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 21 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
- 5 other devices also cite its predicate K191570.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact measurement method for forehead measurement, the recommended measurement distance is 0cm to 3cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.
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/K213079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213079: Ear Thermometer, Model ET001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213079
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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