510(k) · Cleared
ClearedInfrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexmed Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Sep 21, 2016 as substantially equivalent to K131243 (Shenzhen Jumper Medical Equipment Co., Ltd., 2013) after a 181-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Sep 21, 2016
- Review
- 181 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010462 (2001). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 5 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 4 generations backK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- 3 generations backK080759 Thermoflash LX-26Jxb Co. Ltd Guangzhou (China) · 2008
- 2 generations backK102947 Non-Contact Infrared ThermometerK-Jump Health Co., Ltd. · 2011
- 1 generation backK131243 Non-Contact Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd. · 2013
- This deviceK160816 Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360…Nexmed Technology Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK153600 Consult Station TSH4D Sas · 2017
Most influential descendants
Showing 1 of 1 · See all- K153600Consult Station TSH4D Sas · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −5 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −4 | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| −3 | K080759 | Thermoflash LX-26 | Jxb Co. Ltd Guangzhou (China) | 2008 | — |
| −2 | K102947 | Non-Contact Infrared Thermometer | K-Jump Health Co., Ltd. | 2011 | — |
| −1 | K131243 | Non-Contact Infrared Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. | 2013 | — |
| 0 (this device) | K160816 | Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T… | Nexmed Technology Co., Ltd. | 2016 | — |
| +1 | K153600 | Consult Station TS | H4D Sas | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K131243 | Non-Contact Infrared ThermometerSummary page 5…nformation Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. Device: Non-contact Infrared Thermometer 510(K) Number: K131243 5.4 Device Description The subject device uses infrared probe to detect the radiated infrared energy emitted by the object, so… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153600 | Consult Station TS | 2017 | 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?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K153600 (H4D Sas, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K131243.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Infrared Thermometer is intended for body temperature measurement 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/K160816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160816: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160816
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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