510(k) · Cleared

Cleared

Microlife Digital Infrared Ear Thermometer, Model IR1DE1

K020725510(k) SpecialCleared Mar 12, 20026-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 Mar 12, 2002 as substantially equivalent to K000969 (Microlife Corp., 2000) and 1 other predicate after a 6-day review. Its family tree reaches back 1 generation to 2000. 31 later devices descend from it.

Decided: Mar 12, 2002
Review: 6 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K000969 (2000). 2 ancestors in all. 31 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
This deviceK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
Descendant · cites it directly · 23 of its ownK033820 Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004
Descendant · 2 generations on · 18 of its ownK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010
Descendant · 3 generations on · 11 of its ownK191829 Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020
Descendant · cites it directly · 6 of its ownK034023 Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004
Descendant · 3 generations on · 5 of its ownK150869 Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2004high 7 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 31 · See all

K033820Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004 · cites it directly23descendants
K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010 · 2 generations on18descendants
K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020 · 3 generations on11descendants
K034023Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004 · cites it directly6descendants
K150869Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000969	Microlife Digital Infrared Ear Thermometer, Model IR1DA1	Microlife Corp.	2000	—
0 (this device)	K020725	Microlife Digital Infrared Ear Thermometer, Model IR1DE1	Microlife Corp.	2002	—
+1	K033820	Microlife Digital Infrared Forehead Thermometer, Model FR1DM1	Microlife Intellectual Property GmbH	2004	—
+2	K100953	Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1	Microlife Intellectual Property GmbH	2010	—
+3	K191829	Microlife Non-Contact Infrared Forehead Thermometer	Microlife Intellectual Property GmbH	2020	—
+1	K034023	Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1	Microlife Intellectual Property GmbH	2004	—
+3	K150869	Checkme Pro Health Monitor	Viatom Technology Co., Ltd.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	5	0
2009	1	0
2010	1	0
2012	1	0
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	3	0
2020	1	0
2021	7	0
2022	5	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K020725, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K000969	Microlife Digital Infrared Ear Thermometer, Model IR1DA1 Summary page 1 …ital Infrared Ear Thermometer, Model IR1DET1. Information for the 510(k) Cleared Device (Predicate Device): Microlife Digital Infrared Ear Thermometer, Model IR1DA1, K#000969, K#003308. Device Description: The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is an electronic thermometer using…	Microlife Corp.	2000	—
*	K003308	Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1 Summary page 1 …red Ear Thermometer, Model IR1DET1. Information for the 510(k) Cleared Device (Predicate Device): Microlife Digital Infrared Ear Thermometer, Model IR1DA1, K#000969, K#003308. Device Description: The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is an electronic thermometer using an infrare…	Microlife Corp.	2000	—

Also cleared against K000969: 1 other device →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K033820	Microlife Digital Infrared Forehead Thermometer, Model FR1DM1	Microlife Intellectual Property GmbH	2004	23
K034023	Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1	Microlife Intellectual Property GmbH	2004	6
K033818	Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289…	Microlife Intellectual Property GmbH	2004	0
K033817	Microlife Digital Infrared Ear Thermometer, Models IR1DA1-2, IR1DE1-2	Microlife Intellectual Property GmbH	2004	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K033820 (Microlife Intellectual Property GmbH, 2004) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K000969.

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

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

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

Recalls per year · FLL

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	81	0	4
2008	14	59	0	13
2009	13	84	0	9
2010	24	88	0	9
2011	20	113	1	18
2012	17	126	0	26
2013	14	149	0	16
2014	7	199	0	54
2015	3	270	1	53
2016	22	157	0	58
2017	16	174	2	118
2018	35	209	1	51
2019	22	198	5	52
2020	21	194	0	53
2021	43	218	0	115
2022	24	218	0	142
2023	17	295	0	101
2024	13	223	0	118
2025	6	131	1	73
2026	2	—	1	—

What is it indicated for?

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

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

https://510kreport.com/device/K020725 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020725: Microlife Digital Infrared Ear Thermometer, Model IR1DE1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020725

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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