510(k) · Cleared
ClearedActherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actherm, Inc. · FLL Continuous Measurement Thermometer
Cleared on Apr 16, 2009 as substantially equivalent to K031928 (Braun GmbH, 2003) after a 101-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Apr 16, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031928 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
- This deviceK090031 Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for…Actherm, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK093795 Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe…Actherm, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093795Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010Actherm, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun… | Braun GmbH | 2003 | — |
| 0 (this device) | K090031 | Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm… | Actherm, Inc. | 2009 | — |
| +1 | K093795 | Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med… | Actherm, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt…Summary page 1…Clinical Electronic Thermometer (per21 CFR 880.2910) Predicate Device Information: Braun GmbH, Braun Thermoscan 1RT4000 series 510 (k) number is K031928. Code: FDA-008 Version: A Revision Status: 0 Issuing Date: 2008/12/01… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093795 | Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010 | 2010 | 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?
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Actherm Infrared Ear Thermometers ACT8000 Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover medACCU2010.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090031: Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model MEDACCU2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090031
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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