510(k) · Cleared
ClearedDigital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030
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 Jul 7, 2003 after a 17-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 7, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031905 Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330…Actherm, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK070028 Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal…Actherm, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070028Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe…Actherm, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031905 | Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136… | Actherm, Inc. | 2003 | — |
| +1 | K070028 | Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal… | Actherm, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K070028 | Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe… | 2007 | 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?
- Of its descendants, K070028 (Actherm, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Acthemi Digital Clinical Thermometers, KO 1023:3.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031905: Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031905
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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