510(k) · Cleared
ClearedInfrared Thermometer Model MD-H30
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 Nov 13, 2019 as substantially equivalent to K162083 (Radiant Innovation, Inc., 2017) after a 153-day review. Its family tree reaches back 6 generations to 2001. 8 later devices descend from it.
- Decided
- Nov 13, 2019
- Review
- 153 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011059 (2001). 10 ancestors in all, the oldest K011291 (2001). 8 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- 5 generations backK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
- 4 generations backK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
- 3 generations backK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
- 2 generations backK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
- 1 generation backK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
- This deviceK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK213011 Infrared Thermometer (model: E201)Bioland Technology, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK200531 iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK243082 Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK213084 Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213079 Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd. · 2022 · cites it directly1descendant
- K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd. · 2020 · cites it directly1descendant
- K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd. · 2022 · cites it directly0descendants
- K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| −5 | K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | Radiant Innovation, Inc. | 2003 | — |
| −4 | K040377 | Rii Infrared Ear Thermometer, Models Thxxn Series | Radiant Innovation, Inc. | 2004 | — |
| −3 | K051269 | Rii Infrared Ear Thermometer, Models TH00XY Series | Radiant Innovation, Inc. | 2005 | — |
| −2 | K063185 | Rii Infrared Ear Thermometer, Models TH5XY Series | Radiant Innovation, Inc. | 2006 | — |
| −1 | K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. | 2017 | — |
| 0 (this device) | K191570 | Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd. | 2019 | — |
| +1 | K213011 | Infrared Thermometer (model: E201) | Bioland Technology, Ltd. | 2022 | — |
| +1 | K200531 | iHealth Infrared No-Touch Forehead Thermometer | Andon Health Co, Ltd. | 2020 | — |
| +2 | K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025 | — |
| +1 | K213084 | Ear Thermometer, Model ET005, ET008, ET009 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K162083 | RII Multi-function Infrared Thermometer, Model TH52ZSummary page 4…880.2910 3. Legally Marketed Predicate Device Trade Name RII Multi-function Infrared Thermometer, Model TH52Z 510(k) Number K162083 Product Code FLL Manufacturer Radiant Innovation Inc 4. Device Description The Infrare… | 2017 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213011 | Infrared Thermometer (model: E201) | 2022 | 1 |
| K200531 | iHealth Infrared No-Touch Forehead Thermometer | 2020 | 1 |
| K213084 | Ear Thermometer, Model ET005, ET008, ET009 | 2022 | 0 |
| K213079 | Ear Thermometer, Model ET001 | 2022 | 0 |
| K202440 | Infrared Thermometer | 2021 | 0 |
| K200710 | Infrared PT2L Digital No-Touch Thermometer | 2020 | 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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K213011 (Bioland Technology, Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K162083.
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 intended for the intermittent measurement of body temperature from the auditory canal or
central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by
healthcare providers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191570: Infrared Thermometer Model MD-H30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191570
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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