510(k) Report

510(k) · Cleared

Cleared

Temporalscanner Thermometer, Sensortouch

K011291510(k) TraditionalCleared Jul 12, 200176-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

Exergen Corp. · FLL Continuous Measurement Thermometer

Cleared on Jul 12, 2001 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 200 later devices descend from it.

Decided
Jul 12, 2001
Review
76 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

200 later devices descend from it, 17 citing it directly.

Descendants, by year cleared 2010: 7 descendants cleared2014: 5 descendants cleared2004: 1 descendant cleared2019: 16 descendants cleared2016: 10 descendants cleared2012: 7 descendants cleared2021: 28 descendants cleared2020: 13 descendants cleared2003: 2 descendants cleared2005: 3 descendants cleared2009: 2 descendants cleared2007: 3 descendants cleared2011: 3 descendants cleared2008: 3 descendants cleared2013: 3 descendants cleared2015: 4 descendants cleared2018: 14 descendants cleared2017: 10 descendants cleared2026: 7 descendants cleared2023: 15 descendants cleared2022: 20 descendants cleared2024: 10 descendants cleared2025: 14 descendants cleared200020052010201520202025
  1. This deviceK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
  2. Descendant · cites it directly · 80 of its ownK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
  3. Descendant · cites it directly · 67 of its ownK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
  4. Descendant · 2 generations on · 40 of its ownK072108 Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007
  5. Descendant · 2 generations on · 40 of its ownK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
  6. Descendant · 3 generations on · 39 of its ownK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007

Showing 5 of 200 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 32007: 32008: 32009: 22010: 72011: 32012: 72013: 32014: 52015: 42016: 102017: 102018: 142019: 162020: 132021: 282022: 202023: 152024: 102025: 142026: 7
2003high 28 (2021) · low 0 (2006)2026

Most influential descendants

Showing 5 of 200 · See all
  • K033790Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004 · cites it directly80descendants
  • K031503Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003 · cites it directly67descendants
  • K072108Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007 · 2 generations on40descendants
  • K050463Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR…Taidoc Technology Corporation · 2005 · 2 generations on40descendants
  • K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007 · 3 generations on39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011291Temporalscanner Thermometer, SensortouchExergen Corp.2001—
+1K033790Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.2004—
+1K031503Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation2003—
+2K072108Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.2007—
+2K050463Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation2005—
+3K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200530
200730
200830
200920
201070
201130
201270
201330
201450
201540
2016100
2017100
2018140
2019160
2020130
2021280
2022200
2023150
2024100
2025140
202670
FIG. 1 — Lineage of K011291, 2001–2026Source: 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? (200)

See all 200

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

NumberDeviceApplicantDecidedDescendants
K033790Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.200480
K031503Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation200367
K113165Mini-MedicAthena Gtx201213
K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011
K032362UP-Grade Forehead ThermometerMedisim, Ltd.20035
K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143
K101912The Infrared Forehead Thermometer, Model FS-300&301Hubdic Co., Ltd.20102
K191697Cardiac Monitor 1500Zynex Medical, Inc.20201
K161909IQvitals ZoneMidmark Corporation20161
K152043Diagnostic Station DS20Schiller AG20161

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, K033790 (Tecnimed S.R.L., 2004) has gone furthest, with 80 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—

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/K011291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011291: Temporalscanner Thermometer, Sensortouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011291

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