510(k) · Cleared

Cleared

K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100

K060240510(k) AbbreviatedCleared May 19, 2006108-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

K-Jump Health Co., Ltd. · FLL Continuous Measurement Thermometer

Cleared on May 19, 2006 as substantially equivalent to K003326 (Funai Radio & Communications Corp., 2001) after a 108-day review. Its family tree reaches back 1 generation to 2001.

Decided: May 19, 2006
Review: 108 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003326 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
This deviceK060240 K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100K-Jump Health Co., Ltd. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003326	Funet Amy Mama Body Thermometer	Funai Radio & Communications Corp.	2001	—
0 (this device)	K060240	K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100	K-Jump Health Co., Ltd.	2006	—

FIG. 1 — Lineage of K060240, 2001–2006Source: 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
*	K003326	Funet Amy Mama Body Thermometer Summary page 1 …umnp Digital Thermometer with Battery-Less Patch, Model KD-21 00 3. Common or Usual Name: Clinical Electronic Thermometer 4. Predicate Device Informnation: K003326, Funet Amy Mama Body Thermometer, Funal Radio & Communications Corporation 5. Device Description: The Digital Thermom…	Funai Radio & Communications Corp.	2001	—

Also cleared against K003326: 4 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?

Its one ancestor has no recall.
4 other devices also cite its predicate K003326.

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 Digital Thermometer with Battery-Less Patch, Model KD-2100, is intended to measure and monitor human body temperature with a wireless digital LCD reader and a sensor coupled patch. The device is reusable and intended for ear and mouth measurement of adults and pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060240 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060240: K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060240

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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