510(k) Report

510(k) · Cleared

Cleared

Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer

K070028510(k) SpecialCleared Feb 8, 200736-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 8, 2007 as substantially equivalent to K010238 (Actherm, Inc., 2001) and 4 other predicates after a 36-day review. Its family tree reaches back 2 generations to 2001.

Decided
Feb 8, 2007
Review
36 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K010238 (2001). 5 ancestors in all, the oldest K954792 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestorK010238 · Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ · Actherm, Inc. · 2001K021612 · Digital Clinical Thermometer, Models Act 2030, 2038 · Actherm, Inc. · 20021996199820002002200420062008
Other ancestors, by generation 1 generation back: 3 other ancestors K021612 · Digital Clinical Thermometer, Models Act 2030, 2038 · Actherm, Inc. · 2002K010238 · Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ · Actherm, Inc. · 20010
  1. Root · 2 generations backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
  2. 1 generation backK021612 Digital Clinical Thermometer, Models Act 2030, 2038Actherm, Inc. · 2002
  3. This deviceK070028 Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal…Actherm, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010238Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+…Actherm, Inc.2001—
−1K021612Digital Clinical Thermometer, Models Act 2030, 2038Actherm, Inc.2002—
0 (this device)K070028Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal…Actherm, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200210
200310
FIG. 1 — Lineage of K070028, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010238Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+…
Summary page 1
…lectronic Thermometer (21 CFR 880.2910 Product Code FLL) Predicate Device Information Actherm Digital Clinical Thermometer, Model ACT2000, ACT2020 et al. (K010238) Digital Clinical Thermometer, Model ACT2030, ACT2038 (K021612) Digital Clinical Thermometer, Model AC…
Actherm, Inc.2001—
*K021612Digital Clinical Thermometer, Models Act 2030, 2038
Summary page 1
…formation Actherm Digital Clinical Thermometer, Model ACT2000, ACT2020 et al. (K010238) Digital Clinical Thermometer, Model ACT2030, ACT2038 (K021612) Digital Clinical Thermometer, Model ACT3020 (K021614) Digital Clinical Thermometer, Model AC…
Actherm, Inc.2002—
*K021614Digital Clinical Thermometer, Model Act 3020
Summary page 1
…(K010238) Digital Clinical Thermometer, Model ACT2030, ACT2038 (K021612) Digital Clinical Thermometer, Model ACT3020 (K021614) Digital Clinical Thermometer, Model ACT2130, ACT3136 et al. (K031905) Lumiscope Model 2018 Thermometer…
Actherm, Inc.2002—
*K031905Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030
Summary page 1
…(K021612) Digital Clinical Thermometer, Model ACT3020 (K021614) Digital Clinical Thermometer, Model ACT2130, ACT3136 et al. (K031905) Lumiscope Model 2018 Thermometer (K954792)…
Actherm, Inc.2003—
*K954792Lumiscope Model 2018 Thermometer
Summary page 1
…(K021614) Digital Clinical Thermometer, Model ACT2130, ACT3136 et al. (K031905) Lumiscope Model 2018 Thermometer (K954792) A4: 2 of 3…
Lumiscope Co., Inc.1996—

Also cleared against K010238: 3 other devices →

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 6 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K010238.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

All Digital Clinical Thermometers are intended to precisely measure human body temperature. The Thermometers can be used in the measurement of oral, axillary and rectal temperature.

Indications for use as stated in the FDA summary.

Also cleared against K010238

3 other devices cite the same predicate.

  • K072641Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
  • K023500Digital Clinical Thermometer, Model Baby Temp/WL-3305 and Baby Temp (+) /WL-3306Innovatech, Inc. · 2002
  • K021612Digital Clinical Thermometer, Models Act 2030, 2038Actherm, Inc. · 2002

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
  • K031905Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030Actherm, Inc. · 2003
  • K021614Digital Clinical Thermometer, Model Act 3020Actherm, Inc. · 2002

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/K070028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070028: Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070028

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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