510(k) Report

510(k) · Cleared

Cleared

Microlife Digital Infrared Ear Thermometer, Model IR1DA1

K000969510(k) TraditionalCleared Aug 22, 2000148-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

Microlife Corp. · FLL Continuous Measurement Thermometer

Cleared on Aug 22, 2000 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it.

Decided
Aug 22, 2000
Review
148 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

33 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2004: 5 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2010: 1 descendant cleared2017: 2 descendants cleared2009: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2019: 3 descendants cleared2021: 7 descendants cleared2022: 5 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
  2. Descendant · cites it directly · 31 of its ownK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
  3. Descendant · 2 generations on · 23 of its ownK033820 Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004
  4. Descendant · 3 generations on · 18 of its ownK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010
  5. Descendant · 4 generations on · 11 of its ownK191829 Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020
  6. Descendant · 2 generations on · 6 of its ownK034023 Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2002: 22004: 52009: 12010: 12012: 12015: 12016: 12017: 22018: 12019: 32020: 12021: 72022: 52023: 12025: 1
2002high 7 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 33 · See all
  • K020725Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002 · cites it directly31descendants
  • K033820Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004 · 2 generations on23descendants
  • K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010 · 3 generations on18descendants
  • K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020 · 4 generations on11descendants
  • K034023Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000969Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp.2000—
+1K020725Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp.2002—
+2K033820Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH2004—
+3K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH2010—
+4K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH2020—
+2K034023Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200450
200910
201010
201210
201510
201610
201720
201810
201930
202010
202170
202250
202310
202510
FIG. 1 — Lineage of K000969, 2000–2025Source: 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), 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
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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? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K020725Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp.200231
K013876Infrared Ear Thermometer, Model DX-707Jawon Medical Co., Ltd.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, K020725 (Microlife Corp., 2002) has gone furthest, with 31 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 Microlife Corp.

13 FDA decisions under this applicant name. See the company

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  • K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp. · 2008
  • K073398Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp. · 2007
  • K073397Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)Microlife Corp. · 2007
  • K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004

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
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  • 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/K000969 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000969: Microlife Digital Infrared Ear Thermometer, Model IR1DA1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000969

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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