510(k) Report

510(k) · Cleared

Cleared

Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+

K010238510(k) TraditionalCleared Feb 6, 200112-day reviewClass II21 CFR 880.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Actherm, Inc. · FLL Continuous Measurement Thermometer

Cleared on Feb 6, 2001 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Feb 6, 2001
Review
12 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

13 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2002: 2 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2021: 2 descendants cleared2019: 1 descendant cleared2016: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
  2. Descendant · cites it directly · 9 of its ownK072641 Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
  3. Descendant · 2 generations on · 8 of its ownK101387 Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010
  4. Descendant · 3 generations on · 2 of its ownK132514 Kinsa Smart ThermometerKinsa, Inc. · 2013
  5. Descendant · 3 generations on · 1 of its ownK203731 DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021
  6. Descendant · 3 generations on · 1 of its ownK190990 Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002: 22007: 22010: 12013: 12016: 12017: 12018: 12019: 12021: 22023: 1
2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all
  • K072641Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007 · cites it directly9descendants
  • K101387Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010 · 2 generations on8descendants
  • K132514Kinsa Smart ThermometerKinsa, Inc. · 2013 · 3 generations on2descendants
  • K203731DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021 · 3 generations on1descendant
  • K190990Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010238Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+…Actherm, Inc.2001—
+1K072641Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd.2007—
+2K101387Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd.2010—
+3K132514Kinsa Smart ThermometerKinsa, Inc.2013—
+3K203731DT100 Digital ThermometerSmart Technology Co., Ltd.2021—
+3K190990Digital ThermometerXiamen Ants Bro Technology Co., Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200720
201010
201310
201610
201710
201810
201910
202120
202310
FIG. 1 — Lineage of K010238, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072641Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd.20079
K021612Digital Clinical Thermometer, Models Act 2030, 2038Actherm, Inc.20021
K070028Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe…Actherm, Inc.20070
K023500Digital Clinical Thermometer, Model Baby Temp/WL-3305 and Baby Temp (+) /WL-3306Innovatech, Inc.20020

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, K072641 (Famidoc Technology Co., Ltd., 2007) has gone furthest, with 9 descendants of its own.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007: 152008: 142009: 132010: 242011: 202012: 172013: 142014: 72015: 32016: 222017: 162018: 352019: 222020: 212021: 432022: 242023: 172024: 132025: 62026 (partial year): 2
2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007: 81 days median2008: 59 days median2009: 84 days median2010: 88 days median2011: 113 days median2012: 126 days median2013: 149 days median2014: 199 days median2015: 270 days median2016: 157 days median2017: 174 days median2018: 209 days median2019: 198 days median2020: 194 days median2021: 218 days median2022: 218 days median2023: 295 days median2024: 223 days median2025: 131 days median
2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2011: 12015: 12017: 22018: 12019: 52025: 12026 (partial year): 1
2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007: 42008: 132009: 92010: 92011: 182012: 262013: 162014: 542015: 532016: 582017: 1182018: 512019: 522020: 532021: 1152022: 1422023: 1012024: 1182025: 73
2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007158104
20081459013
2009138409
2010248809
201120113118
201217126026
201314149016
20147199054
20153270153
201622157058
2017161742118
201835209151
201922198552
202021194053
2021432180115
2022242180142
2023172950101
2024132230118
20256131173
20262—1—

More from Actherm, Inc.

8 FDA decisions under this applicant name. See the company

  • K093795Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010Actherm, Inc. · 2010
  • K083419Actherm Digital Clinical Thermometer Probe Covers, Model (S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020Actherm, Inc. · 2009
  • K090031Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear Thermometer, Model…Actherm, Inc. · 2009
  • K070028Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical…Actherm, Inc. · 2007
  • K031905Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030Actherm, Inc. · 2003

Recent decisions in FLL

The FLL category page

  • K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature…Unimed Medical Supplies, Inc. · 2026
  • K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026
  • K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd. · 2025
  • K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd. · 2025
  • K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025

https://510kreport.com/device/K010238 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010238: Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010238

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026