510(k) · Cleared

Cleared

Model GT010706 Electronic Thermometer

K021052510(k) TraditionalCleared Apr 9, 20028-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

Global Treasure Industries, Ltd. · FLL Continuous Measurement Thermometer

Cleared on Apr 9, 2002 as substantially equivalent to K961879 (Wiltec Industries, Ltd., 1996) after an 8-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.

Decided: Apr 9, 2002
Review: 8 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K961879 (1996). 6 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK961879 Electronic ThermometerWiltec Industries, Ltd. · 1996
This deviceK021052 Model GT010706 Electronic ThermometerGlobal Treasure Industries, Ltd. · 2002
Descendant · cites it directly · 1 of its ownK062016 Rapid Digital Thermometer, Model RDT -18 SeriesChoice Smart Health Care Co., Ltd. · 2006
Descendant · 2 generations on · 0 of its ownK072635 Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1Ningbo Huahui Medical Instruments Co., Ltd. · 2008
Descendant · cites it directly · 0 of its ownK062010 Rapid Digital Thermometer, Model RDT -18 SeriesGlobal Treasure Industries, Ltd. · 2006
Descendant · cites it directly · 0 of its ownK030673 Flexible Tip Thermometer, Model 011206Global Treasure Industries, Ltd. · 2003
Descendant · cites it directly · 0 of its ownK030658 Standard ThermometerGlobal Treasure Industries, Ltd. · 2003

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all

K062016Rapid Digital Thermometer, Model RDT -18 SeriesChoice Smart Health Care Co., Ltd. · 2006 · cites it directly1descendant
K072635Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1Ningbo Huahui Medical Instruments Co., Ltd. · 2008 · 2 generations on0descendants
K062010Rapid Digital Thermometer, Model RDT -18 SeriesGlobal Treasure Industries, Ltd. · 2006 · cites it directly0descendants
K030673Flexible Tip Thermometer, Model 011206Global Treasure Industries, Ltd. · 2003 · cites it directly0descendants
K030658Standard ThermometerGlobal Treasure Industries, Ltd. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961879	Electronic Thermometer	Wiltec Industries, Ltd.	1996	—
0 (this device)	K021052	Model GT010706 Electronic Thermometer	Global Treasure Industries, Ltd.	2002	—
+1	K062016	Rapid Digital Thermometer, Model RDT -18 Series	Choice Smart Health Care Co., Ltd.	2006	—
+2	K072635	Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1	Ningbo Huahui Medical Instruments Co., Ltd.	2008	—
+1	K062010	Rapid Digital Thermometer, Model RDT -18 Series	Global Treasure Industries, Ltd.	2006	—
+1	K030673	Flexible Tip Thermometer, Model 011206	Global Treasure Industries, Ltd.	2003	—
+1	K030658	Standard Thermometer	Global Treasure Industries, Ltd.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2006	2	0
2008	1	0

FIG. 1 — Lineage of K021052, 1996–2008Source: 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
*	K961879	Electronic Thermometer Summary page 1 …linical electronic thermometer subsection 880.2910 6. Intended device: Clinical electronic thermometer 7. Predicate devices: Wiltec Industries Ltd-Electronic Thermometer-K961879 8. Device description: \| The intended product is an electronic digital thermometer for measuring patient temperature. 9. htenc%ed…	Wiltec Industries, Ltd.	1996	—

Also cleared against K961879: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K062016	Rapid Digital Thermometer, Model RDT -18 Series	Choice Smart Health Care Co., Ltd.	2006	1
K062010	Rapid Digital Thermometer, Model RDT -18 Series	Global Treasure Industries, Ltd.	2006	0
K030673	Flexible Tip Thermometer, Model 011206	Global Treasure Industries, Ltd.	2003	0
K030658	Standard Thermometer	Global Treasure Industries, Ltd.	2003	0
K023538	Timex Accucurve Talking 30 Second Thermomter	Medport, Inc.	2002	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, K062016 (Choice Smart Health Care Co., Ltd., 2006) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K961879.

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?

Indicated use- Measure of individual temperature

Measurements- Oral

Axillary -under arm

Rectal

Range of me‘asurcment— 90.0° -1099° F (32.0° -43°.C)

Accuracy- +-02° F

Targeted population- Individuals requiring temperature measurements

Znvironment of use- Hospital and home

Disposable / reusable- Reusable, clean with alcohol

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/K021052 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021052: Model GT010706 Electronic Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021052

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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