510(k) · Cleared
ClearedActherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010
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 Mar 12, 2010 as substantially equivalent to K090031 (Actherm, Inc., 2009) after a 92-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Mar 12, 2010
- Review
- 92 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031928 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
- 1 generation backK090031 Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for…Actherm, Inc. · 2009
- This deviceK093795 Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe…Actherm, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun… | Braun GmbH | 2003 | — |
| −1 | K090031 | Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm… | Actherm, Inc. | 2009 | — |
| 0 (this device) | K093795 | Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med… | Actherm, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K090031 | Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear…Summary page 1….291 0, Product FLL) Predicate Device Information Actherm Infrared Ear Thermometer ACT 8000 Series and Its Probe Cover medACCU 201 0 510 (k) number: K09003 1. 6F, No. 18, Jhanye 2nd Rd., Hsinchu Science Park, Hsinchu 30078, li 886 36 66 95 96… | 2009 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
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?
Actherm Infrared Ear Thermometers A CT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on pcoplc of all age, and is used with or without probe cover mnedACCU2O 10.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093795: Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093795
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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