510(k) · Cleared

Cleared

E-Care Infared Ear Thermometer, Model LCT-200

K021753510(k) TraditionalCleared Aug 6, 200269-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

E-Care Technology Corporation · FLL Continuous Measurement Thermometer

Cleared on Aug 6, 2002 as substantially equivalent to K983295 (Braun AG, 1999) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1993.

Decided: Aug 6, 2002
Review: 69 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K922344 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK922344 Omron Tympanic Thermometer MC-500Omron Healthcare, Inc. · 1993
This deviceK021753 E-Care Infared Ear Thermometer, Model LCT-200E-Care Technology Corporation · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922344	Omron Tympanic Thermometer MC-500	Omron Healthcare, Inc.	1993	—
0 (this device)	K021753	E-Care Infared Ear Thermometer, Model LCT-200	E-Care Technology Corporation	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K021753, 1993–2002Source: 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 …E-Care Infrared Ear Thermometer, Model LCT-200 3. Predicate Device Information: BraunKhermoScan Instant Thermometer, IRT3020, IRT3520, Braun Ltd. K#983295, Thermoscan Inc. Omron Gentle Temp MC-505, Omron Health Care K#922344, Omron Health Care. 4. Device Descripti…	Braun AG	1999	—
*	K922344	Omron Tympanic Thermometer MC-500 Summary page 1 …rmation: BraunKhermoScan Instant Thermometer, IRT3020, IRT3520, Braun Ltd. K#983295, Thermoscan Inc. Omron Gentle Temp MC-505, Omron Health Care K#922344, Omron Health Care. 4. Device Description: The E-Care Technology Corporation infrared Ear Thermometer, Model…	Omron Healthcare, Inc.	1993	—

Also cleared against K983295: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
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?

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 as stated in the FDA summary.

https://510kreport.com/device/K021753 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021753: E-Care Infared Ear Thermometer, Model LCT-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021753

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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