510(k) · Cleared
ClearediHealth infrared Ear thermometer PT5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jan 28, 2022 as substantially equivalent to K103800 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2011) after a 165-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jan 28, 2022
- Review
- 165 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K031928 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
- 2 generations backK101747 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010
- 1 generation backK103800 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2011
- This deviceK212598 iHealth infrared Ear thermometer PT5Andon Health Co, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun… | Braun GmbH | 2003 | — |
| −2 | K101747 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model… | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2010 | — |
| −1 | K103800 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical… | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2011 | — |
| 0 (this device) | K212598 | iHealth infrared Ear thermometer PT5 | Andon Health Co, Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K103800 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared…Summary page 4…Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometer 510(k) Number: K103800 Classification II Product Code FLL 5.0 Intended Use The Infrared Ear thermometer is intended for the intermitt… | 2011 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K103800.
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 Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities 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/K212598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212598: iHealth infrared Ear thermometer PT5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212598
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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