510(k) · Cleared

Cleared

Microlife Digital Underarm Electronic Thermometer, Model MT 18E1 (V932)

K032364510(k) AbbreviatedCleared Sep 23, 200354-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 Intellectual Property GmbH · FLL Continuous Measurement Thermometer

Cleared on Sep 23, 2003 as substantially equivalent to K851146 (Micro Idea Instrument Co., Ltd., 1985) after a 54-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Sep 23, 2003
Review: 54 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K851146 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK851146 Digital ThermometerMicro Idea Instrument Co., Ltd. · 1985
This deviceK032364 Microlife Digital Underarm Electronic Thermometer, Model MT 18E1…Microlife Intellectual Property GmbH · 2003
Descendant · cites it directly · 0 of its ownK103680 Microlife Digital Underarm ThermometerMicrolife Intellectual Property GmbH · 2011

Most influential descendants

Showing 1 of 1 · See all

K103680Microlife Digital Underarm ThermometerMicrolife Intellectual Property GmbH · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851146	Digital Thermometer	Micro Idea Instrument Co., Ltd.	1985	—
0 (this device)	K032364	Microlife Digital Underarm Electronic Thermometer, Model MT 18E1 (V932)	Microlife Intellectual Property GmbH	2003	—
+1	K103680	Microlife Digital Underarm Thermometer	Microlife Intellectual Property GmbH	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K032364, 1985–2011Source: 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

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What was it cleared against? (1)

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
*	K851146	Digital Thermometer Summary page 1 …ital Underarm Electronic Thermometer, Model MTI 8E1 (V932) 3. Predicate Device Information: Micro Idea Instrument Digital Thermometer, Model MT 3001/5001, K#851146, Microlife Corporation 4. Device Description: Unlike regular thermometers, the unique elbow of the Digital Unde…	Micro Idea Instrument Co., Ltd.	1985	—

Also cleared against K851146: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103680	Microlife Digital Underarm Thermometer	Microlife Intellectual Property GmbH	2011	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?

Its one ancestor has no recall.
Of its descendants, K103680 (Microlife Intellectual Property GmbH, 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K851146.

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?

Microlife Digital Underarm Thermometer MTI 8E1 (V932) is designed specifically for measuring underarm (axillary) temperatures in children ages infant to 6 years old.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032364 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032364: Microlife Digital Underarm Electronic Thermometer, Model MT 18E1 (V932).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032364

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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