510(k) Report

510(k) · Cleared

Cleared

Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520

K983295510(k) TraditionalCleared Mar 15, 1999175-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

Braun AG · FLL Continuous Measurement Thermometer

Cleared on Mar 15, 1999 after a 175-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided
Mar 15, 1999
Review
175 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

11 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2002: 4 descendants cleared2003: 1 descendant cleared2012: 2 descendants cleared2004: 1 descendant cleared2000: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983295 Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model…Braun AG · 1999
  2. Descendant · cites it directly · 1 of its ownK111463 Valeo VT-601 Series IR ThermometerValeo Corp. · 2012
  3. Descendant · cites it directly · 1 of its ownK033077 Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd. · 2004
  4. Descendant · 2 generations on · 0 of its ownK172894 Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd. · 2018
  5. Descendant · 2 generations on · 0 of its ownK163256 Dual Mode Infrared ThermometerIntelliworks, LLC · 2017
  6. Descendant · cites it directly · 0 of its ownK113095 E-Care Infrared Ear ThermometerE-Care Technology Corporation · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2000: 12002: 42003: 12004: 12012: 22017: 12018: 1
2000high 4 (2002) · low 0 (2001)2026

Most influential descendants

Showing 5 of 11 · See all
  • K111463Valeo VT-601 Series IR ThermometerValeo Corp. · 2012 · cites it directly1descendant
  • K033077Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd. · 2004 · cites it directly1descendant
  • K172894Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd. · 2018 · 2 generations on0descendants
  • K163256Dual Mode Infrared ThermometerIntelliworks, LLC · 2017 · 2 generations on0descendants
  • K113095E-Care Infrared Ear ThermometerE-Care Technology Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983295Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520Braun AG1999—
+1K111463Valeo VT-601 Series IR ThermometerValeo Corp.2012—
+1K033077Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd.2004—
+2K172894Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd.2018—
+2K163256Dual Mode Infrared ThermometerIntelliworks, LLC2017—
+1K113095E-Care Infrared Ear ThermometerE-Care Technology Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200240
200310
200410
201220
201710
201810
FIG. 1 — Lineage of K983295, 1999–2018Source: 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), 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? (2)

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
*—ThermoScan® Instant Thermometer, Model IR-4000
Named without a submission number
—
*—ThermoScan® Instant Thermometer, Model IR-6000
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K111463Valeo VT-601 Series IR ThermometerValeo Corp.20121
K033077Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd.20041
K113095E-Care Infrared Ear ThermometerE-Care Technology Corporation20120
K023412Thermo Buddy, Models TB-100, TB-110, TB-120Hubdic Co., Ltd.20030
K021753E-Care Infared Ear Thermometer, Model LCT-200E-Care Technology Corporation20020
K020520Easytem Ear Thermometer, Model BT-020Metatech Co., Ltd.20020
K020471Hivox Ear Thermometer, TS SeriesHivox Biotek, Inc.20020
K013876Infrared Ear Thermometer, Model DX-707Jawon Medical Co., Ltd.20020
K993950Cecilia Penguin Multi-Use Thermometer, Model HP-ETO9999Nien Made Electrnics Corp.20000

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, K111463 (Valeo Corp., 2012) has gone furthest, with 1 descendant 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—

What is it indicated for?

The Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K983295 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983295: Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983295

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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