510(k) · Cleared

Cleared

Easytem Duo, Forehead/Ear Thermometer, Model BT-021

K033077510(k) TraditionalCleared Apr 30, 2004214-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

Metatech Co., Ltd. · FLL Continuous Measurement Thermometer

Cleared on Apr 30, 2004 as substantially equivalent to K983295 (Braun AG, 1999) and 1 other predicate after a 214-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: Apr 30, 2004
Review: 214 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K983295 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK983295 Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model…Braun AG · 1999
This deviceK033077 Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd. · 2004
Descendant · cites it directly · 0 of its ownK163256 Dual Mode Infrared ThermometerIntelliworks, LLC · 2017

Most influential descendants

Showing 1 of 1 · See all

K163256Dual Mode Infrared ThermometerIntelliworks, LLC · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983295	Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520	Braun AG	1999	—
0 (this device)	K033077	Easytem Duo, Forehead/Ear Thermometer, Model BT-021	Metatech Co., Ltd.	2004	—
+1	K163256	Dual Mode Infrared Thermometer	Intelliworks, LLC	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K033077, 1999–2017Source: 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
*	K983295	Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520 Summary page 1 …ass: lI Panel: 80 (General Hospital) Predicate Devices: Braun Thermoscan, IRT-3520 K 983295 (Predicate #1) SAAT ThermoTek 718F K 002712 (Predicate #2)…	Braun AG	1999	—
*	K002712	Thermo Tek IR Forehead Thermometer, Model 718F Summary page 1 …hermoscan, IRT-3520 K 983295 (Predicate #1) SAAT ThermoTek 718F K 002712 (Predicate #2) Page -2- (51 Ok Summary) Device Description: The easytern duo Forehead/Ear Thermomet…	Saat, Ltd.	2001	—

Also cleared against K983295: 8 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
K163256	Dual Mode Infrared Thermometer	Intelliworks, LLC	2017	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, K163256 (Intelliworks, LLC, 2017) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate K983295.

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?

This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033077 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033077: Easytem Duo, Forehead/Ear Thermometer, Model BT-021.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033077

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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