510(k) · Cleared
Recalled · Class II · 2015Digital Forehead Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K-Jump Health Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Apr 4, 2011 as substantially equivalent to K070491 (K-Jump Health Co., Ltd., 2007) after a 115-day review. Its family tree reaches back 4 generations to 1990. It has been recalled once.
- Decided
- Apr 4, 2011
- Review
- 115 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902624 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 3 generations backK983887 UP-Grade and UP-Grade ProMedisim, Ltd. · 1999 · Recalled
- 2 generations backK032362 UP-Grade Forehead ThermometerMedisim, Ltd. · 2003
- 1 generation backK070491 Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd. · 2007
- This deviceK103617 Digital Forehead ThermometerK-Jump Health Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −3 | K983887 | UP-Grade and UP-Grade Pro | Medisim, Ltd. | 1999 | 1 |
| −2 | K032362 | UP-Grade Forehead Thermometer | Medisim, Ltd. | 2003 | — |
| −1 | K070491 | Digital Forehead Thermometer, Model# KD-2200 | K-Jump Health Co., Ltd. | 2007 | — |
| 0 (this device) | K103617 | Digital Forehead Thermometer | K-Jump Health Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K070491 | Digital Forehead Thermometer, Model# KD-2200Summary page 1…r: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: 11 Product Code: FLL 3. Predicate Device Information: - K070491, Digital Forehead Thermometer, Model 1(0-2200, K-jump Health Co., Ltd., Taipei, Taiwan 4. Device Description:… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2015 | Class II | Z-0412-2016 | Process control | An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 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?
K-jump Health Ca, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103617: Digital Forehead Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103617
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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