510(k) · Cleared
ClearedNon-Contact Infrared 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 Feb 25, 2011 as substantially equivalent to K080759 (Jxb Co. Ltd Guangzhou (China), 2008) after a 144-day review. Its family tree reaches back 4 generations to 2001. 8 later devices descend from it.
- Decided
- Feb 25, 2011
- Review
- 144 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010462 (2001). 5 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 3 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 2 generations backK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- 1 generation backK080759 Thermoflash LX-26Jxb Co. Ltd Guangzhou (China) · 2008
- This deviceK102947 Non-Contact Infrared ThermometerK-Jump Health Co., Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK131243 Non-Contact Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK160816 Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360…Nexmed Technology Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK210118 INFRARED BODY THERMOMETER (Model: YK-001)Longnan Renzhong Medical Equipment Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK202111 Medical infrared forehead thermometerHunan Honggao Electronic Technolofy Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK172889 Infrared ThermometerShenzhen Pacom Medical Instruments Co., Ltd. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131243Non-Contact Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd. · 2013 · cites it directly5descendants
- K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. · 2016 · 2 generations on1descendant
- K210118INFRARED BODY THERMOMETER (Model: YK-001)Longnan Renzhong Medical Equipment Co., Ltd. · 2021 · 2 generations on0descendants
- K202111Medical infrared forehead thermometerHunan Honggao Electronic Technolofy Co., Ltd. · 2021 · 2 generations on0descendants
- K172889Infrared ThermometerShenzhen Pacom Medical Instruments Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −3 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −2 | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| −1 | K080759 | Thermoflash LX-26 | Jxb Co. Ltd Guangzhou (China) | 2008 | — |
| 0 (this device) | K102947 | Non-Contact Infrared Thermometer | K-Jump Health Co., Ltd. | 2011 | — |
| +1 | K131243 | Non-Contact Infrared Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. | 2013 | — |
| +2 | K160816 | Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T… | Nexmed Technology Co., Ltd. | 2016 | — |
| +2 | K210118 | INFRARED BODY THERMOMETER (Model: YK-001) | Longnan Renzhong Medical Equipment Co., Ltd. | 2021 | — |
| +2 | K202111 | Medical infrared forehead thermometer | Hunan Honggao Electronic Technolofy Co., Ltd. | 2021 | — |
| +1 | K172889 | Infrared Thermometer | Shenzhen Pacom Medical Instruments Co., Ltd. | 2018 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K080759 | Thermoflash LX-26Summary page 1…r: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: 11 Product Code: FLL 3. Predicate Device Information: - K080759, Thermolash LX-26, JXB Co., Ltd., Guangzhou, China 4. Device Description: The Non-Contact Infrared Thermometer,… | 2008 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131243 (Shenzhen Jumper Medical Equipment Co., Ltd., 2013) has gone furthest, with 5 descendants of its own.
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?
Non-Contact Infrared Thermometer, Model KI-8280, can measure body temperature for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102947 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102947: Non-Contact Infrared Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102947
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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